Titrated oral misoprostol solution versus vaginal misoprostol for labor induction

Objective

To determine the efficacy and safety of a titrated oral misoprostol solution compared with vaginal misoprostol tablets for labor induction.

Methods

A randomized, triple-blind, multicenter clinical trial was conducted between March 2010 and June 2011. Women with a single gestation (n = 200) were randomized to receive a titrated oral misoprostol solution (initial misoprostol dose 20 μg/hour; dose increased by 20 μg/hour every 6 hours up to 80 μg/hour for a maximum of 48 doses) or vaginal misoprostol tablets (25 μg of misoprostol every 6 hours for a maximum of 8 doses). Risk ratios (RR) and 95% confidence intervals (CIs) were calculated for maternal and perinatal outcomes.

Results

The frequencies of vaginal delivery not achieved within 12 hours (RR 0.87; 95% CI, 0.62–1.22) and within 24 hours (RR 1.11; 95% CI, 0.83–1.49) were similar in the 2 groups. No differences were found in terms of uterine hyperstimulation, unfavorable cervix at 12 and 24 hours, oxytocin augmentation, tachysystole, epidural analgesia, adverse effects, and perinatal outcome. Approximately 70% of the women preferred the oral solution.

Conclusion

A titrated oral misoprostol solution was as effective and safe for labor induction as vaginal misoprostol tablets.ClinicalTrial.gov: NCT00 992524     

A pilot study on the combined use of letrozole,mifepristone and misoprostol in termination of first trimester pregnancy up to 9 weeks’ gestation

Objective

To assess the feasibility of adding letrozole to the standard regimen of mifepristone and misoprostol for termination of pregnancy up to 63 days.

Study design

We recruited 50 subjects who had requested legal termination of pregnancy up to 63 days. Medical abortion was performed with a singe dose of 200 mg mifepristone and 10 mg of letrozole daily for 3 days followed by 800 mcg vaginal misoprostol.

Results

The complete abortion rate was 98% (95% CI: 94–100%). The median induction-to-abortion interval of the regimen was 5.1 h (range 1.2–56 h). No serious adverse effects were reported.

Conclusions

The results of this pilot study suggest that a regimen of mifepristone, letrozole and misoprostol is associated with a high complete abortion rate without major adverse events.     

Ensayo clínico aleatorizado para evaluar la eficacia y seguridad de la administración de 25 μg de misoprostol por vía vaginal frente a 50 μg por vía sublingual para la inducción del trabajo del parto en gestantes con diabetes

Objective

To evaluate the safety and efficacy of misoprostol 50 μg administered sublingually versus 25 μg administered vaginally for labor induction at term in pregnant women with diabetes.

Methods

Three hundred pregnant women with diabetes were randomly allocated to receive misoprostol 25 μg vaginally or 50 μg sublingually every 4 hours up to 4 doses. The main variable assessed was the rate of vaginal deliveries in 24 hours.

Results

Vaginal delivery in 24 hours was achieved in 109/150 (72.7%) women in the sublingual group and in 104/150 (69.3%) in the vaginal group, with no statistically significant differences (p = 0.611; RR = 1.176; 95% CI for RR, 0.714-1.938). Tachysystole was significantly more frequent in the sublingual misoprostol group (RR = 0.474; 95% CI for RR, 0.233-0.968). The indications for cesarean section were similar in both groups. Uterine rupture occurred in one patient in the sublingual group who was administered the third misoprostol dose in the active phase of labor.

Conclusions

No statistically significant differences were found in the vaginal delivery rates between sublingual and vaginal misoprostol, although adverse effects were more frequent with the sublingual route.     

Comparison of the effects of raloxifene and anastrozole on experimental endometriosis

Objective

To compare the efficacies of anastrozole and raloxifene on endometriosis.

Study design

A randomized, placebo-controlled, single-blind, experimental study was performed on 45 adult Wistar female rats in the Experimental Surgery Laboratory at Ondokuz Mayis University in Turkey. Endometrial tissues were implanted on the abdominal peritoneum in 45 rats. Six weeks later, the implant volumes were measured (volume-1) by performing a second laparotomy. Rats were randomized to one of three equal study groups. Saline solution (0.1 cc/rat/week, subcutaneously) was administered to group 1 (control group), anastrozole (0.004 mg/rat/day, orally) to group 2 (anastrozole group), and raloxifene (0.24 mg/rat/day, orally) to group 3 (raloxifene group) for 8 weeks. At the end of administration, a third laparotomy was performed to remeasure implant volumes (volume-2), and implants were totally excised for histopathologic examination. Volume-1 and volume-2 within the groups, as well as stromal and glandular tissues between the groups, were compared.

Result(s)

In the anastrozole and raloxifene groups, volume-2 values were significantly lower than those of volume-1. When compared to the control group, in both anastrozole and raloxifene groups, while glandular tissue scores were found significantly lower, stromal tissue scores were not different than that of the control group. There was no significant difference between both the GT and ST scores of the anastrozole and raloxifene groups.

Conclusion(s)

Anastrozole and raloxifene were seen to have caused equally the regression of the experimental endometriosis statistically significantly.     

A randomized controlled trial on the value of misoprostol for the treatment of retained placenta in a low-resource setting

Objective

To evaluate the efficacy and safety of misoprostol among patients with retained placenta in a low-resource setting.

Methods

A prospective, multicenter, randomized, double-blind, placebo-controlled trial was carried out in Tanzania between April 2008 and November 2011. It included patients who delivered at a gestational age of 28 weeks or more and had blood loss of 750 mL or less at 30 minutes after delivery. Sublingual misoprostol (800 μg) was compared with placebo as the primary treatment. Power analysis showed that 117 patients would be required to observe a reduction of 40% in the incidence of manual removal of the placenta (MRP; P = 0.05, 80% power), the primary outcome. The secondary outcomes were blood loss and number of blood transfusions.

Results

Interim analysis after recruitment of 95 patients showed that incidence of MRP, total blood loss, and incidence of blood transfusions were similar in the misoprostol (MRP, 40%; blood loss, 803 mL; blood transfusion, 15%) and placebo (MRP, 33%, blood loss 787 mL, blood transfusion, 23%) groups. The trial was stopped because continuation would not alter the interim conclusion that misoprostol was ineffective.

Conclusion

Treatment with misoprostol was found to have no clinically significant beneficial effect among women with retained placenta.Clinical Trial Registration: Current Controlled Trials ISRCTN16104753     

Efficacy and acceptability of a mifepristone–misoprostol combined regimen for early induced abortion among women in Mexico City

Objective

To evaluate the experience of women receiving mifepristone–misoprostol for early induced abortion in public sector facilities in the Federal District of Mexico City.

Methods

An open-label prospective study was conducted with 1000 pregnant women who sought induced abortion with a pregnancy of up to 63 days of gestation, as measured from the date of their last menstrual period. The study was conducted in three public sector healthcare facilities: two secondary level hospitals and one primary care clinic. Women ingested 200 mg mifepristone on day 1, followed by 800 μg buccal misoprostol 24 hours later, and they returned for follow-up on day 8. The primary outcome was complete abortion without recourse to surgical intervention.

Results

A total of 971 women received mifepristone–misoprostol and were included in the analysis for efficacy of treatment. The overall efficacy of the combined medical abortion regimen studied was 97.3% (n = 945); the success rate did not vary significantly by gestational age (95.9%–100%; P = 0.449). Most women (n = 922, 95.0%) had a successful induced abortion with only one dose of misoprostol.

Conclusion

The combined mifepristone and buccal misoprostol regimen was found to be highly effective and acceptable among Mexican women. www.ClinicalTrials.gov: NCT00386282.     

Effect of a single preoperative dose of sublingual misoprostol on intraoperative blood loss during total abdominal hysterectomy

Objective

To investigate whether use of preoperative misoprostol can reduce blood loss during total abdominal hysterectomy (TAH).

Methods

In a randomized double-blind placebo-controlled trial at a tertiary care hospital in Kolkata, India, between March 2011 and April 2012, women (n = 132) undergoing TAH with or without bilateral salpingo-oophorectomy for symptomatic myomas were randomly allocated to receive either 400 μg of misoprostol or placebo 30 minutes before surgery. The primary outcome measure was intraoperative blood loss was. The secondary outcomes were postoperative drop in hemoglobin, need for blood transfusion, and incidence of adverse effects.

Results

The 2 groups were similar with regard to demographic and clinical characteristics. There was a significant reduction of blood loss during TAH after sublingual administration of misoprostol compared with placebo before surgery (356 mL vs 435 mL; P = 0.049). The mean postoperative hemoglobin concentration was higher (10.5 g/dL vs 9.5 g/dL; P < 0.001) and the postoperative drop in hemoglobin was smaller (1.1 g/dL vs 1.9 g/dL; P = 0.004) in the misoprostol group than in the placebo group. No significant adverse effects occurred in either group.

Conclusion

The results showed that a single dose of misoprostol administered before abdominal hysterectomy resulted in a significant reduction of blood loss with minimal adverse effects.Clinical Trial Registry India (www.ctri.nic.in): CTRI/2011/091/000216.     

Efficacy of mifepristone for cervical priming for second-trimester surgical termination of pregnancy

Objective

To determine whether mifepristone plus misoprostol was as effective as misoprostol with or without laminaria (depending on gestational age) for cervical preparation for second-trimester termination of pregnancy.

Methods

A retrospective cohort study was carried out among women who underwent surgical termination between 14 and 19 + 6 weeks of pregnancy. Those who received preoperative mifepristone were compared with those who did not. The study group received mifepristone plus misoprostol before dilation and evacuation of the uterus between May 2008 and September 2011. The comparison (non-mifepristone) group received misoprostol with or without laminaria between January 2005 and April 2008.

Results

There was no difference between the groups in terms of difficulty of cervical dilation, with an overall relative risk for moderate–difficult dilation in the mifepristone group of 0.91 (95% confidence interval, 0.49–1.68). There was no difference between the groups with regard to complications arising from the procedure.

Conclusion

Mifepristone is effective for cervical priming prior to second-trimester dilation and evacuation in both multiparous and primiparous women, without an increase in complication rates.     

Ensayo clínico,aleatorizado y controlado para evaluar la eficacia y la seguridad de la administración de 25 μg de misoprostol vaginal frente a 50 μg de misoprostol sublingual para la inducción del trabajo del parto

Objectives

To compare the safety and efficacy of 25 μg of vaginal misoprostol versus 50 μg of sublingual misoprostol for induction of labor.

Patients and methods

Four hundred fifty women were randomly assigned to receive 25 μg of vaginal misoprostol or 50 μg of sublingual misoprostol every 4 h for up to four doses. The main outcome assessed was the number of vaginal deliveries in 24 h.

Results

A total of 155/225 (68.9%) patients in the sublingual group and 154/225 (68.4%) women in the vaginal group delivered vaginally (p = 0.920; RR = 1.021; 95% CI for RR, 0.685-1.521). The mean time (± standard deviation) for starting labor was 2.75 ± 2.20 h in the sublingual group and 3.8 ± 2.77 h in the vaginal group (p < 0.001). The mean number (± standard deviation) of doses was 1.9 ± 0.8 in the vaginal group and 1.6 ± 0.8 in the sublingual group (p = 0.010). Indications for cesarean section and the frequency of tachysystole were similar in both groups. There was a greater need for oxytocin in the vaginal group (22.7%) than in the sublingual group (14.7%) (p = 0.020).

Conclusions

No statistically significant differences were found between the 2 treatment groups in the main variable: the number of vaginal deliveries in 24 h.     

Análisis del valor del misoprostol en el tratamiento del aborto diferido

Objective

To study the use of misoprostol as an alternative management for early pregnancy loss.

Materials and methods

Patients (n = 109) diagnosed with early pregnancy loss between December 2009 and December 2010 were offered medical treatment with 600 μg intravaginal misoprostol or surgical curettage.

Results

Ninety-two patients (84.40%) received medical treatment and 17 (15.60%) were treated surgically. Medical treatment was successful in 78 patients (84.8%). Compared with surgery, medical treatment was more painful (visual analog scale 1-10) (6.29 [2.46] vs. 4.24 [3.35]; P = .026), required fewer days of absence from work (3.0 [1.3-7.0) vs. 6.5 [4.0-14.8]; P = .007), and increased the need for painkillers (P = .014). Overall satisfaction (scale 1-10) was higher with surgery 9.33 (1.32) vs. 8.26 (1.64) P = .024. The cost of medical treatment was 123,04 euros lower per procedure.

Conclusion

Medical treatment with misoprostol was successful in almost 90% of patients, with few adverse effects, a good satisfaction rate and lower cost than surgical curettage.     

Dosing interval of 24 hours versus 48 hours between mifepristone and misoprostol administration for mid-trimester termination of pregnancy

Objective

To compare the efficacy of a shorter interval (24 hours) between misoprostol and mifepristone administration with that of the conventional dosing interval (48 hours) for second-trimester termination of pregnancy (TOP).

Methods

This was a prospective randomized, controlled, open-label study of 98 healthy women opting for mid-trimester TOP. The women were randomized to receive 200 mg mifepristone orally, followed 24 hours (Group 1) or 48 hours (Group 2) later by misoprostol (800 μg, then 400 μg every 3 hours). The primary outcome measure was the percentage of successful abortions within 24 hours. Secondary outcome measures were the induction-to-abortion interval (measured from misoprostol administration) and the frequencies of complications and adverse effects.

Results

The rate of successful abortions was similar with the 24-hour and 48-hour dosing intervals (95.8% and 93.6%, respectively; P = 0.38). The mean induction-to-abortion interval was also comparable between the 2 groups (8.6 ± 4.1 hours versus 8.7 ± 3.9 hours; P = 0.37). Nulliparous women and women with a pregnancy duration of 16 weeks or more had a longer induction-to-abortion interval in both groups.

Conclusion

The 24-hour dosing interval between misoprostol and mifepristone administration seems to be as effective as the 48-hour dosing interval for second trimester TOP.Clinical Trial Registry India: CTRI/2011/05/001770.     

Changes in sexual function and quality of life after single-incision mid-urethral sling for treatment of female stress urinary incontinence

Objectives

To evaluate the effectiveness and assess the changes in sexual function and quality of life after placement of a single-incision sling for the treatment of female stress urinary incontinence.

Study design

A prospective study of women diagnosed with stress urinary incontinence. The single-incision sling was implanted and patients were followed postoperatively for 6 months. The postoperative rate of continence, complications, changes in sexual function, and patient-reported quality of life were evaluated. Female Sexual Function in sexually active patients was evaluated before and after the single-incision sling procedure using the Female Sexual Function Index. From January 2009 to November 2011, 73 patients were enrolled and underwent the procedure to implant the MiniArc^® or Ajust^® single-incision sling.

Results

Overall, 93.2% of the patients who successfully received a single-incision sling demonstrated total restoration of continence (83.6%) or improved continence (9.6%) at the 6-month postoperative visit. Improvements were seen in the quality of life scores related to global bladder feeling (87.7%) and the Female Sexual Function Index (preoperative score 23.86 ± 5.67 vs postoperative score 27.25 ± 4.66 [P < 0.0001]).

Conclusion

Single-incision sling treatment for stress urinary incontinence led to improvements in continence and sexual function at 6 months of postoperative follow-up.     

Effect of leonurine hydrochloride on endothelin and the endothelin receptor-mediated signal pathway in medically-induced incomplete abortion in rats

Objective

Endothelin (ET) is involved in uterine contractions. Our previous study showed that leonurine hydrochloride (LH) inhibits abnormal bleeding caused by incomplete abortion through an increase in uterine contractions in rats. The present study was conducted to show that LH treatment regulates the ET-mediated signal pathway in abortion in rats.

Study design

Early pregnancies in rats had incomplete abortions induced using mifepristone in combination with misoprostol. After the abortions, the rats were treated with LH orally for 7 days and surgery was performed. The sinistro-uterus was dissected for measurement of ET and nitric oxide (NO); the dextro-uterus was stored at −80°C for ET receptor (ET_A and ET_B) analysis. Myometrial cells from the dextro-uterus were cultured for measurement of phospholipase C (PLC) activity, intra-cellular Ca²⁺ concentration ([Ca²⁺]_i), and protein kinase C (PKC) activity.

Results

In in vivo experiments, LH treatment elevated the ET level and ET/NO ratio in rats with induced abortions and up-regulated ET_A mRNA expression (P < 0.01 vs. the model group), but there was no change in ET_B mRNA. LH significantly increased the [Ca²⁺]_i, PLC activity, and relative production of PKC protein in myometrial cells.

Conclusion

LH increased uterine contractions in rats with incomplete abortions by modulating the ET receptor-mediated signal pathway.     

Home administration of misoprostol for early medical abortion in India

Objective

To assess the efficacy and acceptability of home administration of misoprostol for early medical abortion in Indian family planning clinics.

Methods

In this prospective cohort study, consenting pregnant women (n = 599) with amenorrhea of 8 weeks or less seeking termination of pregnancy received 200 mg of oral mifepristone followed 48 hours later with 400 µg of oral misoprostol, administered either at home or at the clinic.

Results

Almost all women (88.4%) chose to take misoprostol home. There was no statistical difference in success rates between home and clinic users (89.0% vs 92.4%, Pearson χ² = 0.7; P = 0.395). Most women in both the home (90.7%) and clinic (92.3%) groups were satisfied or very satisfied with the procedure.

Conclusion

Home administration of misoprostol is safe and feasible for introduction into medical abortion services in India.     

Decentralizing postabortion care in Senegal with misoprostol for incomplete abortion

Objective

To expand access to postabortion care (PAC) services in Senegal by introducing misoprostol as a first-line treatment at the community level.

Methods

The present prospective study enrolled 481 women seeking treatment for incomplete abortion at 11 community health posts in Senegal between September 2011 and August 2012. Participants were given 400 μg of sublingual misoprostol and asked to return to the clinic 1 week later to confirm clinical status. At study completion, all women were asked to respond to a series of questions regarding their experience with this method. All care was provided by nurse midwives.

Results

All but three of the study women (99.4%; 474/477) had successful complete abortion after taking misoprostol. Almost all women were satisfied or very satisfied with the treatment (99.6%; 469/471), would select the method again if needed (98.9%; 465/470), and would recommend the method to a friend (99.8%; 468/469).

Conclusion

The results provide further evidence that 400 μg of misoprostol is highly effective for first-line treatment of incomplete abortion. Furthermore, this regimen can be fully provided by nurse midwives, and can be easily and successfully introduced in community health settings where other methods of PAC may not previously have been available. Clinicaltrials.gov: NCT01939457     

Acceptability and feasibility of medical abortion with mifepristone and misoprostol in Nigeria

Objective

To examine the acceptability and feasibility of medical abortion in Nigeria.

Methods

In total, 250 women who were eligible for legal pregnancy termination with a gestational age of up to 63 days since last menstrual period were enrolled in Benin City and Zaria between May 2005 and October 2006. Participants received 200 mg of oral mifepristone in the clinic and then took 400 μg of oral misoprostol 2 days later—choosing to either return to the clinic or take it at home. Women returned 2 weeks later for an assessment of abortion status.

Results

The vast majority (96.3%) of women had successful complete abortions. Ultrasound was used to determine outcome in less than one-third (28.9%) of participants. Most women (83.2%) took the misoprostol at home. Almost all (96.2%) participants were satisfied or very satisfied with the abortion method.

Conclusion

The introduction of medical abortion with mifepristone and misoprostol could greatly expand current method options and improve the quality of reproductive health care in Nigeria and other settings in which access to legal abortion services is limited.     

The association of IL-1β, IL-2, and IL-6 gene polymorphisms with bone mineral density and osteoporosis in postmenopausal women

Objective

Osteoporosis is a common disorder with a strong genetic component. The genetics of osteoporosis impacts on the prediction, diagnosis, prognosis, and treatment of the disease.

Study design

The aim of the present study was to examine associations between cytokine gene polymorphisms (IL-1β, IL-2, IL-6) and bone mineral density (BMD) values in postmenopausal women.The study included 226 postmenopausal women with a diagnosed BMD T-score lower than −2.5 SD (mean: −3.02 ± .053) and 224 postmenopausal women with a BMD T-score greater than −2.5 SD (mean: −1.33 ± 0.51).

Results

Among the women with T-scores below −2.5 SD, the BMD values were significantly lower in the carriers of the IL-6 GG genotype compared with those with the CC and GC genotypes (0.70 ± 0.38 vs. 0.73 ± 0.25 and 0.74 ± 0.23 for the lumbar spine, 0.54 ± 0.18 vs. 0.56 ± 0.15 and 0.58 ± 0.22 for the femoral neck). There were no statistically significant associations between the IL-1β and IL-2 genotypes and BMD values in the group of women with T-scores below −2.5 SD.

Conclusion

The results of the present study suggest an association of the IL-6 −174 G/C polymorphism with osteoporosis in postmenopausal women.     

Comparación de la efectividad de la pulsioximetría y el electrocardiograma fetal en las situaciones de riesgo de pérdida de bienestar fetal

Objective

To evaluate the effectiveness of pulse oximetry and fetal electrocardiogram in the management of labor with fetal heart rate patterns associated with a risk of loss of fetal well-being.

Subjects and methods

We performed an open, randomized, experimental trial with two groups: pulse oximetry was used in one group and the STAN® technique was used in the other. Each group included 40 women with single, term pregnancies in cephalic presentation and fetal heart rate patterns associated with a risk of loss of fetal well-being. The overall cesarean section rate, indications of risk of fetal distress, and neonatal acid-base balance were evaluated.

Results

No significant differences were found in the rate of cesarean section (47.5 vs 40%; P = .33), indications of risk of fetal distress (32.5 vs 37.5%; P = .41), or neonatal outcomes.

Conclusions

The use of pulse oximetry and STAN®21, as auxiliary methods to cardiotocographic recording, showed no superiority in reducing the cesarean section rate or improving neonatal outcomes.