Rectal Misoprostol Versus Oxytocin in the Management of the Third Stage of Labour

ObjectiveTo compare the effect of rectal misoprostol with intramuscular oxytocin in the routine management of the third stage in a rural developing country.MethodsA randomized controlled trial was performed at two district hospitals in Ghana, West Africa. Four hundred fifty women in advanced labour were enrolled. The only exclusion criterion was a known medical contraindication to prostaglandin administration. Women were randomized to receive rectal misoprostol 800 μg or intramuscular oxytocin 10 IU with delivery of the anterior shoulder. The main outcome measure was change in hemoglobin concentration from before to after delivery. Secondary outcomes included the need for additional uterotonics, estimated blood loss, transfusion, and medication side effects.ResultsDemographic characteristics were similar in each treatment group. There was no significant difference between treatment groups in change in hemoglobin (misoprostol 1.19 g/dL and oxytocin 1.16 g/dL; relative difference 2.6%; 95% confidence intervals [CI]-16.8% to 19.4%; P = 0.80). The only significant secondary outcome was shivering, which was more common in the misoprostol group (misoprostol 7.5% vs. oxytocin 0.9%; relative risk 8.0; 95% CI 1.86—34.36; P = 0.001).ConclusionRectal misoprostol 800 μg is as effective as 10 IU intramuscular oxytocin in minimizing blood loss in the third stage of labour. Rectal misoprostol has a lower incidence of side effects than the equivalent oral dose. This confirms the utility of misoprostol as a safe and effective uterotonic for use in the rural and remote areas of developing nations where other pharmacologic agents may be less feasible.     

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.     

A Randomized Trial of Laminaria Tents Versus Vaginal Misoprostol for Cervical Ripening in First Trimester Surgical Abortion

Objective: To compare the use of laminaria tents with misoprostol for cervical ripening prior to first trimester surgical abortion.Method: In a prospective, open-label, randomized trial, 70 women were assigned to have either insertion of a 3 mm intracervical laminaria tent or vaginal misoprostol 200 µg on the day prior to suction dilatation and curettage (D&C). Cervical dilatation and operating time were measured at the time of D&C; the surgeon subjectively rated the ease of dilatation. The women were interviewed just prior to the D&C with regard to pain, vaginal bleeding, and dilator preference.Results: Laminaria produced significantly (P < 0.001) greater pre-abortion dilatation of the cervix (34.8 Pratt ± 6.2) than did misoprostol (28.4 Pratt ± 5.8). There was no demonstrable difference in ease of dilatation or operating time. Women randomized to use of laminaria reported significantly more pain on insertion than did those who received misoprostol (P < 0.001). Conversely, misoprostol was associated with more vaginal bleeding (P < 0.01). Pain following insertion was similar in each group. Two patients aborted completely after misoprostol alone. Overall, the stated patient preference for cervical dilator was more likely to be misoprostol (P < 0.01).Conclusions: Laminaria tents are more effective cervical dilators than vaginal misoprostol when inserted the day prior to suction D&C. Vaginal misoprostol insertion is more comfortable, although it is associated with an increased risk of vaginal bleeding and may abort the pregnancy. Patient preference favours misoprostol. In patient-centred care, both laminaria and misoprostol are suitable options for cervical preparation prior to suction D&C.     

Randomised Controlled Trial of Sublingual and Rectal Misoprostol in the Prevention of Primary Postpartum Haemorrhage in a Resource-Limited Community

Background/PurposeMisoprostol is beneficial in preventing postpartum haemorrhage (PPH). However, there is no consensus yet as to which route will give the balance of efficacy, safety and patient preference, especially at the recommended dose of 600 mcg. This study compared the efficacy and adverse effects of rectal and sublingual misoprostol for the prevention of PPH.MethodsIn a prospective fashion, consenting eligible parturients were randomised into two groups to receive either 600 mcg of misoprostol rectally or sublingually after vaginal delivery. All study participants were followed up till 24 h postpartum. Primary outcomes were blood loss of 500 ml or greater and at least 10% change in peripartum haematocrit levels.ResultsSeven (6.7%) and 16 (15.7%) of the sublingual and rectal routes, respectively, had PPH. However, the odds of having PPH after rectal misoprostol were at least twice the odds after the sublingual route (p = 0.041). Also, the mean blood loss after the first, fourth and 24th hour postpartum were significantly higher after rectal administration. Although significantly more patients had shivering and pyrexia after sublingual misoprostol, it was acceptable to more participants than the rectal route.ConclusionAt the recommended dose, sublingually administered misoprostol (‘the sweet of life’) is associated with a lower incidence of PPH than the rectal route. Despite its higher incidence of shivering and pyrexia, it was accepted by more women than rectally administered misoprostol.ClinicalTrials.gov identifier PACTR201911500348367.     

Intraumbilical Oxytocin for the Management of Retained Placenta: A Randomized Controlled Trial

Objective: To evaluate the ability of intraumbilical oxytocin injection as a treatment for retained placenta after vaginal delivery to reduce the incidence of manual removal and postpartum hemorrhage.Methods: A randomized controlled trial was set up in a university and a district general hospital. We recruited 81 women with singleton pregnancies who underwent vaginal delivery and who failed to deliver the placenta after 20 minutes of active management of the third stage of labor. Study subjects were randomized to receive either 1) an intraumbilical injection of oxytocin (20 IU in 20 mL of saline); 2) an intraumbilical injection of saline (20 mL); or 3) no treatment. Outcome measures were expulsion of the placenta within 45 minutes of delivery, need for manual removal of the placenta under anesthesia, and postpartum hemorrhage (defined as a blood loss greater than 500 mL).Results: Women given an intraumbilical injection of oxytocin had a significant increase in spontaneous expulsion of the placenta within 45 minutes of delivery and fewer manual removals of the placenta, compared with women without treatment (odds ratio [OR] 11.6, 99% confidence interval [CI] 1.4, 272.8; and OR 7.4, 99% CI 1.1, 86.5; respectively). When women given intraumbilical oxytocin were compared with women given only intraumbilical saline, the difference was not statistically significant (OR 6.6, 99% CI 0.9, 77.2 for spontaneous expulsion of the placenta; and OR 4.7, 99% CI 0.8, 39.5 for manual removal). There was no significant difference in the incidence of spontaneous expulsion and manual removal of the placenta between women given intraumbilical saline injection and women without treatment (OR 1.8, 99% CI 0.1, 53.9; and OR 1.6, 99% CI 0.1, 22.4; respectively).Conclusion: The results of our study suggest a clinically important beneficial effect of intraumbilical oxytocin injection in the management of retained placenta.     

Afterpains: A Comparison Between Active and Expectant Management of the Third Stage of Labor

Abstract: Background: Management of the third stage of labor, the period following the birth of the infant until delivery of the placenta, is crucial. Active management using synthetic oxytocin has been advocated to decrease blood loss. It has been suggested, but not studied, that oxytocin may increase afterpains. The aim of this study was to compare women’s experience of pain intensity when the third stage of labor was managed actively and expectantly and their experience of afterpains. Methods: A single‐blind, randomized, controlled trial was performed at two delivery units in Sweden in a population of healthy women with normal, singleton pregnancies, gestational age of 34 to 43 weeks, cephalic presentation, and expected vaginal delivery. Women (n = 1,802) were randomly allocated to either active management or expectant management of the third stage of labor. Afterpains were assessed by Visual Analog Scale (VAS) and the Pain‐o‐Meter (POM‐WDS) 2 hours after delivery of the placenta and the day after childbirth. Results: At 2 hours after childbirth, women in the actively managed group had lower VAS pain scores than expectantly managed women (p = 0.014). Afterpains were scored as more intense the day after, compared with 2 hours after, childbirth in both groups. Multiparas scored more intense afterpains, compared with primiparas, irrespective of management (p < 0.001). Conclusions: Active management of the third stage of labor does not provoke more intense afterpains than expectant management. (BIRTH 38:4 December 2011)     

The Third Stage of Labour in the Extremely Obese Parturient

Background

Maternal obesity has been associated with an increased risk for an abnormal progression of labour; however, less is known about the length of the third stage of labour and its relation to maternal obesity.

Randomized Double Masked Trial of Zhi Byed 11, a Tibetan Traditional Medicine,Versus Misoprostol to Prevent Postpartum Hemorrhage in Lhasa,Tibet

The objective of this study was to compare a Tibetan traditional medicine (the uterotonic Zhi Byed 11 [ZB11]) to oral misoprostol for prophylaxis of postpartum hemorrhage (PPH). We conducted a double‐blind randomized controlled trial at three hospitals in Lhasa, Tibet, People's Republic of China. Women (N = 967) were randomized to either ZB11 or misoprostol groups. Postpartum blood loss was measured in a calibrated blood collection drape. The primary combined outcome was incidence of PPH, defined as measured blood loss (MBL) ≥ 500 mL, administration of open label uterotonics, or maternal death. We found that the rate of the combined outcome was lower among the misoprostol group (16.1% versus 21.8% for ZB11; P = .02). Frequency of PPH was lower with misoprostol (12.4% versus 17.4%; P = .02). There were no significant differences in MBL > 1000 mL or mean or median MBL. Fever was significantly more common in the misoprostol group (P = .03). The rate of combined outcome was significantly lower among women receiving misoprostol. However, other indices of obstetric hemorrhage were not significantly different.     

Views of Mothers and Midwives Participating in the Bristol Randomized,Controlled Trial of Active Management of the Third Stage of Labor

Abstract: Mothers and midwives who had participated in the Bristol randomized controlled trial of active versus physiologic management of the Third Stage of Labor were asked for their views. One hundred ninety-one mothers (11% of the total randomized) and 49 midwives completed self-administered questionnaires. Both mothers and midwives commented adversely about the length of the third stage under physiologic management. In general, their views were in accord with the conclusions of the main trial (based on clinical data, including maternal blood loss, length of third stage, need for therapeutic oxytocic agents, and specified neonatal morbidity) in favor of continuing with the current practice of active management.     

Perineal Outcomes and Maternal Comfort Related to the Application of Perineal Warm Packs in the Second Stage of Labor: A Randomized Controlled Trial

ABSTRACT: Background: Perineal warm packs are widely used during childbirth in the belief that they reduce perineal trauma and increase comfort during late second stage of labor. The aim of this study was to determine the effects of applying warm packs to the perineum on perineal trauma and maternal comfort during the late second stage of labor. Methods: A randomized controlled trial was undertaken. In the late second stage of labor, nulliparous women (n = 717) giving birth were randomly allocated to have warm packs (n = 360) applied to their perineum or to receive standard care (n = 357). Standard care was defined as any second‐stage practice carried out by midwives that did not include the application of warm packs to the perineum. Analysis was on an intention‐to‐treat basis, and the primary outcome measures were requirement for perineal suturing and maternal comfort. Results: The difference in the number of women who required suturing after birth was not significant. Women in the warm pack group had significantly fewer third‐ and fourth‐degree tears and they had significantly lower perineal pain scores when giving birth and on “day 1” and “day 2” after the birth compared with the standard care group. At 3 months, they were significantly less likely to have urinary incontinence compared with women in the standard care group. Conclusions: The application of perineal warm packs in late second stage does not reduce the likelihood of nulliparous women requiring perineal suturing but significantly reduces third‐ and fourth‐degree lacerations, pain during the birth and on days 1 and 2, and urinary incontinence. This simple, inexpensive practice should be incorporated into second stage labor care. (BIRTH 34:4 December 2007)     

Misoprostol dose-related shivering and pyrexia in the third stage of labour. WHO Collaborative Trial of Misoprostol in the Management of the Third Stage of Labour.

OBJECTIVE: To select the misoprostol dose to be used in a large multicentre randomised trial comparing misoprostol with oxytocin in the routine management of the third stage of labour. DESIGN: Randomised pilot trial, double-blinded with the use of double placebos. SETTING: Two of the nine hospitals that will participate in the main multicentre trial. The hospitals were located in Johannesburg, South Africa and Khon Kaen, Thailand. POPULATION: Women during second stage of labour about to be delivered vaginally. METHODS: The trial had three arms: misoprostol 400 microg versus misoprostol 600 microg versus intramuscular oxytocin 10 IU. Each group received an injection and three tablets immediately after the birth of the baby. MAIN OUTCOME MEASURES: Shivering and pyrexia rates were the main outcome measures. Data on other side effects and characteristics of the third stage of labour were also collected. Side effects were noted as none, mild, moderate or severe. RESULTS: Both shivering and pyrexia (temperature > 38 degrees C) were most common in the 600 microg misoprostol group (28% and 7.5% for shivering and pyrexia, respectively) compared with 400 microg misoprostol (19% and 2%), and the oxytocin group (12.5% and 3%). The increase in shivering in the misoprostol 600 microg group was due primarily to a higher rate of moderate shivering. None of the women had a temperature > 40 degrees C. There were no increases in severe side effects and other adverse events in the misoprostol 600 microg group. CONCLUSIONS: When used in the management of the third stage of labour oral misoprostol is associated with an increase in the rate of moderate shivering and pyrexia which seems to be dose-related. Based on the results of this pilot trial, the Steering Committee has decided to use 600 microg misoprostol in the main trial, comparing it with oxytocin, in order to achieve higher effectiveness.     

Effectiveness of Vaginal Misoprostol and Rectal Nonsteroidal Anti-Inflammatory Drug in Vaginoscopic Diagnostic Outpatient Hysteroscopy in Primarily Infertile Women: Double-Blind,Randomized, Controlled Trial

Study ObjectiveTo assess whether vaginally administered misoprostol or rectally administered nonsteroidal anti-inflammatory drug reduces pain during vaginoscopic diagnostic outpatient hysteroscopy in nulliparous infertile patients.DesignDouble-blinded, randomized, controlled trial (Canadian Task Force classification I).SettingDepartment of reproductive medicine at a university teaching hospital.PatientsOne hundred fifty-eight primarily infertile women who underwent outpatient hysteroscopy for evaluation of infertility.InterventionsPatients were randomly assigned to 3 groups. Women in group 1 received 200 μg misoprostol vaginally at 6 hours before outpatient hysteroscopy and placebo tablets rectally at 60 minutes before the procedure. Women in group 2 received placebo tablets rectally at 6 hours before outpatient hysteroscopy and 100 mg diclofenac sodium rectally at 60 minutes before the procedure. Women in group 3 received placebo tablets vaginally at 6 hours before outpatient hysteroscopy and placebo tablets rectally at 45 to 60 minutes before the procedure. Patients were asked to record severity of pain, which was the primary outcome of the study, during the outpatient hysteroscopy procedure by using a visual analog scale ranging from 1 (very favorable) to 10 (very unfavorable). Secondary outcomes included procedural time from introduction of the hysteroscope through the external cervical os and visualization of the uterine cavity, patient acceptance recorded by the patient using a 5-point Likert scale, post-procedural analgesic requirements, and vasovagal effects.Measurements and Main ResultsMedian (range) pain scores for the women in group 1 (4.75 [3.12–6.54]) and group 2 (5.01 [2.8–7.05]) were not significantly different from those in group 3 (4.15 [2.17–6.92]) (p = .57). There was also no significant difference in patient acceptance (Likert scale) (p = .67), vasovagal symptoms (p = .84), procedure time (p = .05), and post-procedural analgesic requirement (p = .71).ConclusionsWe were unable to demonstrate a benefit in pain reduction and patient acceptance with the use of vaginal misoprostol or rectal NSAIDs during vaginoscopic diagnostic outpatient hysteroscopy in nulliparous infertile women without a history of cervical stenosis. Trials investigating the optimal time for vaginal misoprostol premedication for pain relief in vaginoscopic outpatient hysteroscopy are needed. New interventions and/or drugs should be studied to decrease pain perception during vaginoscopic outpatient hysteroscopy.     

第三产程产后出血防治措施的分析

目的 :探讨第三产程产后出血的防治措施。方法 :前瞻性观察我院住院分娩的产妇 45 0例 ,其中阴道分娩30 0例 ,随机分为 5组。A组 :缩宫素组 (6 0例 ) ,于胎儿娩出后静脉推注生理盐水 2 0ml加缩宫素 2 0U ;B组 :卡前列甲酯组 (6 0例 ) ,于胎儿娩出后将卡前列甲酯 1mg塞肛 ;C组 :手法按摩组 (6 0例 ) ,胎儿娩出后手法持续宫底按摩≥ 5分钟 ,适度牵拉脐带 ;D组 :缩宫素加手法按摩组 (6 0例 ) ;对照组 (6 0例 ) :于胎儿娩出后静脉滴注生理盐水 5 0 0ml。另 15 0例剖宫产分娩者 ,随机分为 3组 ,A组 :缩宫素组 (5 0例 ) ;B组 :手法组 (5 0例 ) ;C组 :缩宫素加手法组 (5 0例 )。准确测量产后 2小时及 2 4小时出血量 ,记录第三产程时间。结果 :阴道分娩各组中 ,D组的第三产程时间最短 ,产后 2小时内出血量最少 ,C组、B组、A组依次减少 ;剖宫产各组中 ,C组的产后出血量及产后出血发生率与A组、B组相比 ,差异有显著性 ;剖宫产组产后出血量与阴道分娩组比较 ,其差异也有统计学意义。结论 :胎儿娩出后及时使用缩宫素或卡前列甲酯等促宫缩药 ,并采取主动手法辅助娩出胎盘 ,可减少产后出血 ,其预防产后出血的效果显著优于上述其他处理方法。     

Integration of the Practice of Active Management of the Third Stage of Labor Within Training and Service Implementation Programming in Zambia

Introduction: Postpartum hemorrhage (PPH) is the leading cause of pregnancy‐related mortality (cited at 591 per 100,000 Zambian women), and is responsible for up to 60% of maternal deaths in developing countries. Active management of the third stage of labor (AMTSL) has been endorsed as a means of reducing the risk of PPH. The Ministry of Health/Zambia has incorporated the use of AMTSL into its reproductive health guidelines. Methods: Midwives employed in five public hospitals and eight health centers were interviewed (N = 62), and 82 observations were conducted during the second through fourth stages of labor. Results: Data from facilities in which oxytocin was available (62 births in 11 settings) indicated that a uterotonic was used in 53 of the births (85.5%); however, AMTSL was conducted in strict accord with the currently recommended protocol (a time‐specific use of the uterotonic, controlled cord traction, and fundal massage) in only 25 (40.4%) of births. Discussion: Midwives have concerns about risks of maternal to newborn HIV blood transfusion; it is doubtful that they will adopt the currently recommended practice of delayed cord clamping and cutting. Infrastructure issues and supply shortages challenged the ability to correctly and safely implement the AMTSL protocol; nevertheless, facilities were generally ready to support it.