Oral misoprostol for third stage of labor: a randomized placebo-controlled trial.

OBJECTIVE: To investigate whether orally administered misoprostol during the third stage of labor is efficient in reducing postpartum blood loss. METHODS: In a double-masked trial, during vaginal delivery women were randomly assigned to receive a single oral dose of misoprostol (600 microg) or placebo in third stage of labor, immediately after cord clamping. The third stage of labor was managed routinely by early cord clamping and controlled cord traction; oxytocin was administered only if blood loss seemed more than usual. Blood loss was estimated by the delivering physician and differences in hematocrit were measured before and after delivery. RESULTS: Mean (+/- standard error of the mean) estimated blood loss (345 +/- 19.5 mL versus 417 +/- 25.9 mL, P = .031) and hematocrit difference (4.5 +/- 0.9% versus 7.9 +/- 1.2%, P = .014) were significantly lower in women who received misoprostol than those who received placebo. Fewer women in the misoprostol group had postpartum hemorrhage (blood loss of at least 500 mL), but that difference was not statistically significant (7% versus 15%, P = .43). Additional oxytocin before or after placental separation was used less often in the misoprostol group (16% versus 38%, P = .047). There were no differences in the length of third stage of labor (8 +/- 0.9 minutes versus 9 +/- 1 minutes, P = .947). There were no differences in pain during third stage of labor, postpartum fever, or diarrhea, but shivering was more frequent in the misoprostol group. CONCLUSION: Oral misoprostol administered in the third stage of labor reduced postpartum blood loss and might be effective in reducing incidence of postpartum hemorrhage.     

The effect of prophylactic oral tranexamic acid plus buccal misoprostol on blood loss after vaginal delivery: a randomized controlled trial

Objective: The objective of this study is to evaluate the effect of prophylactic oral tranexamic acid (TA) plus buccal misoprostol on the amount of blood loss after vaginal delivery in women at low risk for post-partum hemorrhage (PPH).

Materials and methods: The study was a randomized open label clinical trial conducted in a tertiary University Hospital between January 2016 and June 2017. We included women who delivered vaginally with a singleton pregnancy. They were randomized into three groups: group I (women received 10?IU oxytocin IV after delivery of the baby), group II (women received 600?µg buccal misoprostol after delivery of the baby), and group III (women received 1000?mg oral TA at the end of the first stage of labor plus 600 µg buccal misoprostol after delivery of the baby). In each group, pre- and post-delivery pulse rate, blood pressure, temperature, and hemoglobin level were evaluated. Additionally, the amount of blood loss, need for blood transfusion, need for additional uterotonics, and side effects of the study medications were recorded.

Results: There was a statistically significant lower hemoglobin level and higher blood loss in the misoprostol group compared with oxytocin group and TA plus misoprostol group (p?=?.0001). There was a statistically significant higher hemoglobin level and lower blood loss in the TA plus misoprostol group compared with the oxytocin group (p?=?.004 and .043, respectively). PPH occurred in 16.7% of women in the misoprostol group compared 1.7% in the oxytocin group and no cases of PPH in the TA plus misoprostol group (p?=?.0001).

Conclusions: In settings like rural area or home delivery in which oxytocin is not available, alternative oral TA plus buccal misoprostol may be considered as an effective line in prevention of PPH.     

Role of Misoprostol 600 mcg Oral in Active Management of Third Stage of Labor: A Comparative Study with Oxytocin 10 IU i.m

Objectives

To compare oral misopostol 600 mcg with 10 IU units oxytocin i.m. in the active management of the third stage of labor.

Materials and Methods

A total of 200 pregnant women of 34–42 weeks of gestation delivering vaginally in the Rajendra Institute of Medical Sciences, Ranchi, were selected for study. Hundred women received oral misoprostol 600 mg and 100 women received i.m. oxytocin 10 IU immediately after delivery of the baby and cord clamping by the method of randomization.

Results

In the misoprostol group, mean blood loss is 145 ml, mean duration of the third stage of labor is 3.76 min, and mean fall in hemoglobin is 0.55 g/dl. In the oxytocin group, mean blood loss in 125.6 ml, mean duration of the third stage of labor in 3.50 min, and mean fall in hemoglobin is 0.48 g/dl. There was no significant difference between the two groups with regard to the above-mentioned factors. There were 8 cases of PPH in the misoprostol group and 6 cases in the oxytocin group. Twenty-two cases in the misoprostol group and 16 cases in the oxytocin group required additional oxytocics. Adverse effects like shivering and pyrexia were more in the misoprostol group.

Conclusion

Oral misoprostol is as effective as oxytocin in AMTSL and can be used safely in vaginal deliveries for prevention of PPH, especially in non-institutional deliveries and in places of low resource settings.     

Misoprostol versus oxytocin in the third stage of labor.

OBJECTIVES: A double blind randomized controlled trial was performed at the tertiary hospital in Harare, Zimbabwe to compare oral misoprostol with intramuscular oxytocin in the management of third stage of labor. METHODS: A total of 499 women were randomized to receive either 400 microg misoprostol orally or 10 IU oxytocin intramuscularly. The incidences of postpartum hemorrhage and side effects were examined. RESULTS: The demographic and labor characteristics were comparable. Postpartum hemorrhage occurred in 15.2% of women given misoprostol and in 13.3% of those given oxytocin (P=0.534). Measured blood loss of more than 1000 ml occurred in 3.7% of the misoprostol group compared with 2% in the oxytocin group (P=0.237). There was no significant difference in the need for additional oxytocic drugs or blood transfusion in women given misoprostol (P values 0.137 and 0.600, respectively). Significant side effects of misoprostol were shivering [RR=1.32 (95% CI 1.11-1.58); P=0.002) and a rise in temperature [RR=2.02 (95% CI 1.75-2.33); P<0.001]. CONCLUSIONS: Oral misoprostol is as effective as intramuscular oxytocin in the prevention of PPH. Shivering and transient pyrexia were specific side effects of misoprostol. Misoprostol has potential in reducing the high incidence of PPH in developing countries.     

A Comparative Study of Oxytocin/Misoprostol/Methylergometrine for Active Management of the Third Stage of Labor

Objectives

To study oxytocin, misoprostol, and methylergometrine in active management of the third stage of labor and determine duration of the third stage of labor, blood loss, adverse effects, and need for additional uterotonics in each group.

Methods

Clinical trial of 300 women with healthy singleton pregnancy allocated into three groups to receive either: 10 IU intravenous oxytocin infusion, 600 μg sublingual misoprostol, or 200 μg intravenous methylergometrine. Primary outcome measure was blood loss in the third stage of labor; secondary measures were duration of the third stage, side effects, and complications.

Results

Subjects who received 600 μg of misoprostol had the least blood loss, followed by oxytocin, and methylergometrine. The shortest mean duration of the third stage was with misoprostol. Shivering and pyrexia were observed in misoprostol group, and raised blood pressure in methylergometrine group.

Conclusions

Misoprostol is as effective as oxytocin and both are more effective than methylergometrine in active management of the third stage of labor.     

Misoprostol and active management of the third stage of labor.

OBJECTIVE: To compare current practices for the active management of the third stage of labor (AMTSL) with the use of 600 mug of oral misoprostol. METHODS: An operations research study was designed to compare blood loss with current AMTSL practices and misoprostol use. RESULTS: Women in the misoprostol group were less likely to bleed 500 ml or more (adjusted odds ratio, 0.30; 95% confidence interval, 0.16-0.56) compared with those in the current practices group. In the current practices group 73% women required interventions because of postpartum hemorrhage, compared with 11% in the misoprostol group. CONCLUSION: In situations where oxytocin and or ergometrine are not consistently and appropriately used during third stage of labor, misoprostol should be considered for inclusion in the AMTSL protocol.     

A pilot-randomized comparison of sublingual misoprostol with syntometrine on the blood loss in third stage of labor

BACKGROUND: To compare sublingual misoprostol with intravenous syntometrine use during third stage of labor by measuring the blood loss. METHODS: Sixty women were randomized to receive either 600 micro g misoprostol sublingually or 1 ml syntometrine intravenously during the third stage of labor after spontaneous vaginal delivery. For those with risk factors of postpartum hemorrhage such as medical induction or augmentation of labor, previous third stage complications were excluded. The blood loss in labor was measured by the alkaline-hematin method, and differences in hemoglobin before and after delivery were compared. RESULTS: There was no significant difference in the median measured blood loss between the misoprostol group and the syntometrine group (280 versus 226 ml, p = 0.45). The change in hemoglobin was comparable between the two groups. There were more women in the misoprostol group who required additional oxytocics, but the difference was not statistically significant. A major complication occurred in one patient in the misoprostol group with blood loss in excess of 1000 ml. The incidence of side effects such as shivering and pyrexia in women receiving misoprostol was significantly higher than that in the syntometrine group. CONCLUSION: The use of sublingual misoprostol or intravenous syntometrine in spontaneous vaginal delivery resulted in a comparable amount of blood loss. Transient side effect such as fever and shivering which resolved within a day occurred more frequent to those who received sublingual misoprostol.     

Sublingual misoprostol versus intravenous oxytocin in prevention of post-partum hemorrhage

Background

Post-partum hemorrhage (PPH) is the most common direct cause of maternal mortality and timely intervention can save many lives.

Objective

To compare the effectiveness of sublingual misoprostol to intravenous oxytocin in preventing post-partum hemorrhage in low risk vaginal birth.

Methods

One hundred patients with no risk factor for PPH were randomly allocated to receive 600 μg misoprostol administered sublingually or 10 IU of intravenous oxytocin immediately after the delivery of baby. Main outcome measures were post-partum blood loss, drop in hemoglobin in 24 h, duration of third stage of labor, and drug-related adverse effects.

Results

Mean age, parity and gestational age were similar in both groups. Mean blood loss was significantly lower in oxytocin group (114.28 ± 26.75 versus 149.50 ± 30.78 ml; p = 0.00). Drop in hemoglobin was 0.31 ± 0.16 versus 0.49 ± 0.21 g% (p = 0.01) in oxytocin and misoprostol group, respectively. Duration of third stage labor was shorter in oxytocin group (median 5 min, IQR: 4.5–5.5 versus 5.5 min, IQR: 5–6 min, p < 0.01). Although fever and shivering were common adverse effects with misoprostol but were not clinically significant.

Conclusion

Intravenous oxytocin is more efficacious than sublingual misoprostol in preventing PPH in institutional deliveries.     

Oral misoprostol for the prevention of primary post-partum hemorrhage during third stage of labor

AIM: To assess the effectiveness of oral misoprostol compared with methylergometrine in the prevention of primary post-partum hemorrhage during the third stage of labor. METHODS: This was a randomized controlled trial of 864 singleton low-risk pregnant women. The outcomes were total blood loss, duration of the third stage of labor and peripartal change in hematocrit. Comparisons were by the chi2-test and Student t-test. Relative risks were calculated for side-effects profile. A P-value of less than 0.05 was statistically significant. RESULTS: The biodata of all the participants were similar. The mean blood loss for the misoprostol and methylergometrine groups was 191.6 +/- 134.5 mL and 246.0 +/- 175.5 mL, respectively (95% CI: -79.3 to -39.5 mL). The mean duration of the third stage of labor was 19.6 +/- 2.4 min and 9.4 +/- 3.3 min in the misoprostol and methylergometrine groups, respectively (95% CI: 9.82-10.58 min). More subjects had blood loss >500 mL, 42 (9.7%) versus 6 (1.4%), and peripartal hematocrit change greater than 10%, 38 (8.8%) versus 5 (1.2%), in the methylergometrine group than in the misoprostol group, respectively. Also, more subjects received additional oxytocic in the methylergometrine group, compared to the misoprostol group (80 [18.5%] versus 33 [7.6%] patients, respectively). CONCLUSIONS: Orally administered misoprostol was more effective in reducing blood loss during the third stage of labor than intramuscular methylergometrine. However, there were more subjects in the misoprostol group in whom duration of the third stage of labor was greater than 15 min and who also had manual placental removal than in the methylergometrine group.     

Systematic review of randomized controlled trials of misoprostol to prevent postpartum hemorrhage

OBJECTIVE: To assess the effects of prophylactic misoprostol use in the third stage of labor compared with injectable uterotonics or placebo or no treatment. DATA SOURCES: The Cochrane Pregnancy and Childbirth Group trials register; the Cochrane Library, including databases such as the database of systematic reviews and the Cochrane Controlled Trials Register; and MEDLINE were searched. Researchers in the field were also contacted. The date of the latest search was March 1, 2002. METHODS OF STUDY SELECTION: Randomized trials comparing misoprostol with injectable oxytocin or oxytocin-ergot preparations to prevent postpartum hemorrhage or placebo/no treatment as active management of the third stage of labor were eligible for inclusion. Eligibility and trial quality were assessed following selected criteria. Data were extracted and analyzed using RevMan software. TABULATION, INTEGRATION, AND RESULTS: Sixteen randomized trials with a total of 28,138 women were considered. Data were available for 27,498 women. Oral misoprostol (600 microg) is less effective than injectable uterotonics in reducing blood loss at least 1000 mL (relative risk [RR] 1.36, 95% confidence interval [CI] 1.17, 1.58) and increases the use of additional uterotonics. Shivering and pyrexia (temperature greater than 38C) are the main side effects of misoprostol and are dose related. Compared with injectable uterotonics, the RR of "any shivering" with misoprostol (600 microg) is 3.27 (95% CI 3.01, 3.56) and pyrexia is 6.96 (95% CI 5.65, 8.57). The RR of blood loss of 500 mL or more is 1.11 (95% CI 0.87, 1.43) and the RR of use of additional uterotonics is 1.80 (1.13, 2.85) in the three trials (1441 women) comparing rectal misoprostol (400 microg) with injectable uterotonics. CONCLUSION: Injectable oxytocin or oxytocin-ergot preparations are more effective than misoprostol as part of the active management of the third stage of labor.     

Misoprostol in the management of the third stage of labour in the home delivery setting in rural Gambia: a randomised controlled trial

OBJECTIVE: To assess the effectiveness of 600 microg oral misoprostol on postpartum haemorrhage (PPH) and postpartum anaemia in a low income country home birth situation. DESIGN: Double blind randomised controlled trial. SETTING: Twenty-six villages in rural Gambia with 52 traditional birth attendants (TBAs). SAMPLE: One thousand, two hundred and twenty-nine women delivering at home under the guidance of a trained TBA. METHODS: Active management of the third stage of labour using three 200-microg misoprostol tablets and placebo or four 0.5-mg ergometrine tablets (standard treatment) and placebo. Tablets were taken orally immediately after delivery. MAIN OUTCOME MEASURES: Measured blood loss, postpartum haemoglobin (Hb), difference between Hb at the last antenatal care visit and three to five days postpartum. RESULTS: The misoprostol group experienced lower incidence of measured blood loss > or =500 mL and postpartum Hb <8 g/dL, but the differences were not statistically significant. The reduction in postpartum (compared with pre-delivery) Hb > or = 2 g/dL was 16.4% with misoprostol and 21.2% with ergometrine [relative risk 0.77; 95% confidence interval (CI) 0.60-0.98; P= 0.02]. Shivering was significantly more common with misoprostol, while vomiting was more common with ergometrine. Only transient side effects were observed. CONCLUSIONS: Six hundred micrograms of oral misoprostol is a promising drug to prevent life-threatening PPH in this setting.     

Misoprostol for prevention of postpartum hemorrhage.

OBJECTIVE: To compare the effectiveness of 400 microg rectal misoprostol in 5 cm(3) of saline with oxytocin 10 IU, i.m., in reducing bleeding during the third stage of labor. DESIGN: A double blind, randomized, clinical trial including 663 women with uncomplicated vaginal delivery who received misoprostol (n=324) or oxytocin (n=339). MAIN OUTCOME MEASURES: Changes in hemoglobin and hematocrit from before to 72 h postpartum; blood loss during the third stage; duration of the third stage of labor; need for additional oxytocic drug; frequency of requisition and of administration of blood; changes in blood pressure; and occurrence of side effects. RESULTS: No significant differences were observed between groups, before and 72 h postpartum, in mean hemoglobin and hematocrit, on volume of blood loss and duration of third stage of labor. The incidence of shivering and mean temperature (P<0.01) was significantly greater among women receiving misoprostol than oxytocin. CONCLUSIONS: Misoprostol administered as a micro-enema, 400 microg in 5 ml of saline during the third stage of labor, appears to be as effective as oxytocin 10 IU, i.m., but misoprostol produced more side effects than oxytocin.     

Controlling postpartum hemorrhage after home births in Tanzania.

OBJECTIVES: Determine safety of household management of postpartum hemorrhage (PPH) with 1000 microg of rectal misoprostol, and assess possible reduction in referrals and the need for additional interventions. METHODS: Traditional birth attendants (TBAs) in Kigoma, Tanzania were trained to recognize PPH (500 ml of blood loss). Blood loss measurement was standardized by using a local garment, the "kanga". TBAs in the intervention area gave 1000 microg of misoprostol rectally when PPH occurred. Those in the non-intervention area referred the women to the nearest facility. RESULTS: 454 women in the intervention and 395 in the non-intervention areas were eligible. 111 in the intervention area and 73 in the non-intervention had PPH. Fewer than 2% of the PPH women in the intervention area were referred, compared with 19% in the non-intervention. CONCLUSION: Misoprostol is a low cost, easy to use technology that can control PPH even without a medically trained attendant.     

Effect of oral misoprostol after second-trimester delivery: a randomized,blinded study

OBJECTIVE: To determine whether serial oral misoprostol shortens the third stage of labor in second-trimester pregnancy loss. METHODS: This was a randomized, double-blind, placebo-controlled study of women between 13 and 28 weeks' gestation admitted for spontaneous or induced pregnancy termination. Subjects were randomized to receive either misoprostol (200 microg) or placebo orally every hour for a maximum of three doses if the placenta had not delivered spontaneously within 10 minutes of the fetus. A dilute oxytocin infusion was given to women in both groups. The patients were managed expectantly until intervention was required or up to 6 hours when curettage was scheduled. RESULTS: One hundred eighteen women were randomized to misoprostol and 119 randomized to placebo. Fifty-eight (49%) and 55 (46%) of the misoprostol and placebo groups, respectively, did not receive their medication (P =.65, chi(2) test). There was no difference between the groups with regard to demographic features, method of pregnancy termination, or gestational age. Sixty-seven (57%) and 62 (52%) of the misoprostol and placebo groups, respectively, completed the third stage of labor within 2 hours (P =.47, chi(2) test). There was no statistically significant difference in the median time from fetus to placenta (60 versus 91 minutes in the misoprostol versus placebo group, P =.57, Mann-Whitney U test). There was no difference between the groups in the incidence of hemorrhage, need for transfusion, or curettage rate. CONCLUSION: The therapeutic use of oral misoprostol in the third stage of labor in second-trimester pregnancy loss does not reduce the time to complete spontaneous placental delivery.     

Advance distribution of misoprostol for the prevention of postpartum hemorrhage in South Sudan

Objective

To determine if high uterotonic coverage can be achieved in South Sudan through a facility- and community-focused postpartum hemorrhage (PPH) prevention program.

Methods

The program was implemented from October 2012 to March 2013. At health facilities, active management of the third stage of labor (AMTSL) was emphasized. During prenatal care and home visits, misoprostol was distributed to pregnant women at approximately 32 weeks of pregnancy for the prevention of PPH at home births. Data on uterotonic coverage and other program outcomes were collected through facility registers, home visits, and postpartum interviews.

Results

In total, 533 home births and 394 facility-based births were reported. Misoprostol was distributed in advance to 787 (84.9%) pregnant women, of whom 652 (82.8%) received the drug during home visits. Among the women who delivered at home, 527 (98.9%) reported taking misoprostol. A uterotonic for PPH prevention was provided at 342 (86.8%) facility-based deliveries. Total uterotonic coverage was 93.7%. No adverse events were reported.

Conclusion

It is feasible to achieve high coverage of uterotonic use in a low-resource and postconflict setting with few skilled birth attendants through a combination of advance misoprostol distribution and AMTSL at facilities. Advance distribution through home visits was key to achieving high coverage of misoprostol use.     

A Study to Compare the Efficacy of Misoprostol, Oxytocin, Methyl-ergometrine and Ergometrine–Oxytocin in Reducing Blood Loss in Active Management of 3rd Stage of Labor

Objectives

The purpose of the study was to compare the efficacy of misoprostol 400 μg per rectally, injection oxytocin 10 IU intramuscular, injection methylergometrine 0.2 mg intravenously and injection (0.5 mg ergometrine + 5 IU oxytocin) intramuscular on reducing blood loss in third stage of labor, duration of third stage of labor, effect on haemoglobin of the patient, need of additional oxytocics or blood transfusion and associated side effects and complications.

Study Design

A prospective non-randomized uncontrolled study was carried out in the Department of Obstetrics and Gynecology, SSG Hospital and Medical College, Baroda enrolling 200 women and dividing them into four groups. Active management of 3rd stage of labor was done using one of the 4 uterotonics as per the group of the patient. The main outcome measures were the amount of blood loss, the incidence of postpartum hemorrhage and a drop in hemoglobin concentration from before delivery to 24 h after delivery.

Results

Methylergometrine was found to be superior to rest of the drugs in the study with lowest duration of third stage of labor (P = 0.000096), lowest amount of blood loss (P = 0.000017) and lowest incidence of PPH (P = 0.03). There was no significant difference in the pre-delivery and the post-delivery hemoglobin concentration amongst the four groups with P = 0.061. The need of additional oxytocics and blood transfusion was highest with misoprostol as compared to all other drugs used in the study with P = 0.037 and 0.009, respectively. As regards side effects, misoprostol was associated with shivering and pyrexia in significantly high number of patients as compared to the other drugs used in the study while nausea, vomiting and headache were more associated with methylergometrine and ergometrine–oxytocin. However all the side effects were acceptable and preferable to the excessive blood loss.

Conclusion

Methylergometrine has the best uterotonic drug profile amongst the drugs used, strongly favouring its routine use as oxytocic for active management of third stage of labor. Misoprostol was found to cause a higher blood loss compared to other drugs and hence should be used only in low resource setting where other drugs are not available. The role of misoprostol in third stage of labor needs larger studies to be proved.     

Comparison of sublingual misoprostol, intravenous oxytocin, and intravenous methylergometrine in active management of the third stage of labor

Objective

To compare the efficacy and adverse effects of sublingual misoprostol, intravenous oxytocin, and intravenous methylergometrine in active management of the third stage of labor (AMTSL).

Methods

A double-blind randomized trial of 300 women with a healthy singleton pregnancy allocated into 4 groups to receive either: 400 µg or 600 µg of sublingual misoprostol, 5 IU of intravenous oxytocin, or 200 µg of intravenous methylergometrine. The primary outcome measure was blood loss in the third and fourth stage of labor; secondary measures were duration of the third stage of labor, changes in hemoglobin levels, and adverse effects.

Results

Patients who received 600 µg of misoprostol had the lowest blood loss (96.05 ± 21.1 mL), followed by 400 µg of misoprostol (126.24 ± 49.3 mL), oxytocin (154.7 ± 45.7 mL), and methylergometrine (223.4 ± 73.7 mL) (P < 0.01). Shortest mean duration of the third stage of labor (5.74 minutes) was with 600 µg of misoprostol, while methylergometrine had the longest (6.83 minutes) (P < 0.05). Pyrexia was observed in the misoprostol groups, and raised blood pressure in the methylergometrine group (P < 0.001). The 24-hour postpartum hemoglobin level was similar among the groups (P > 0.05).

Conclusion

Administration of 600 µg of sublingual misoprostol was more effective than 400 µg of misoprostol, intravenous oxytocin, and intravenous methylergometrine for AMTSL.     

Is rectal misoprostol really effective in the treatment of third stage of labor? A randomized controlled trial

OBJECTIVE: The purpose of this study was to compare misoprostol 600 microg intrarectally with conventional oxytocics in the treatment of third stage of labor. STUDY DESIGN: In a controlled trial, 1606 women were randomly grouped to receive (1) oxytocin 10 IU plus rectal misoprostol, (2) rectal misoprostol, (3) oxytocin 10 IU, and (4) oxytocin 10 IU plus methylergometrine. The main outcome measures were the incidence of postpartum hemorrhage and a drop in hemoglobin concentration from before delivery to 24 hours after delivery. RESULTS: The incidence of postpartum hemorrhage was 9.8% in the group that received only rectal misoprostol therapy compared with 3.5% in the group that received oxytocin and methylergometrine therapy (P =.001). There were no significant differences among the 4 groups with regard to a drop in hemoglobin concentrations. Significantly more women needed additional oxytocin in the group that received only rectal misoprostol therapy, when compared with the group that received oxytocin and methylergometrine therapy (8.3% vs 2.2%; P <.001). The primary outcome measures were similar in the group that received only rectal misoprostol therapy and the group that received only oxytocin therapy. CONCLUSION: Rectal misoprostol is significantly less effective than oxytocin plus methylergometrine for the prevention of postpartum hemorrhage.     

A double-blind placebo controlled randomised trial of misoprostol and oxytocin in the management of the third stage of labour

Objective To compare oral misoprostol 400 μg with intramuscular oxytocin 10 IU in the routine management of the third stage.
Design Double-blind placebo controlled trial.
Setting Main referral hospital and its associated polyclinics in Accra, Ghana.
Population Four hundred and one low risk women, in the second stage of labour with anticipated vaginal delivery, who entered labour spontaneously.
Methods After delivery of the anterior shoulder of the baby, the women were randomised to receive either: 1. misoprostol 400 μg powder in water orally and 1 mL normal saline intramuscular injection (placebo); or 2. powdered cellulose in water orally (placebo) and 1 mL oxytocin 10 IU intramuscular injection.
Main outcome measures Change in haemoglobin concentration from before delivery to 12 hours postpartum. Secondary outcomes included need for additional oxytocics, blood loss > 500 mL and > 1000 mL, operative intervention for postpartum haemorrhage, and side effects, including nausea, vomiting, diarrhoea, shivering and elevated temperature.
Results Demographic characteristics were similar. There was no significant difference in change in haemoglobin concentration between the two groups (0.60 g/dL for misoprostol and 0.55 g/dL for oxytocin; relative difference 9.6%; 95% CI 20.5–39.6%;   P = 0.54  ). There were no significant differences in secondary outcomes with the exception of shivering, which occurred more frequently in the misoprostol group (22.2% vs 5.7%; relative risk 4.73; 95% CI 2.31–9.68;   P < 0.0001  ).
Conclusions In low risk women oral misoprostol appears to be as effective in minimising blood loss in the third stage of labour as intramuscular oxytocin. Shivering was noted more frequently with misoprostol use, but no other side effects were noted. Misoprostol has great potential for use in the third stage of labour especially in developing countries.