Comparison Between Preoperative Vaginal and Postoperative Sublingual Misoprostol for Prevention of Postpartum Hemorrhage During Cesarean Section

NCT06765473 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: Pre-vaginal+ Postperative PPH
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cesarean section (CS) is one of the most frequently performed operative interventions worldwide \[1\]. Cesarean section rates increase each year throughout the world. Cesarean delivery can lead to some serious maternal and fetal complications \[2\] including primary postpartum hemorrhage (PPH). Primary PPH is defined as a blood loss of more than 1000 ml during the first 24 hours after delivery \[3\], and it is the most common cause of maternal mortality worldwide \[4\]. Misoprostol is a synthetic prostaglandin E1 analog, commonly used for the prevention and management of PPH. It has potent uterotonic properties and fewer side effects at therapeutic doses \[5\]; it is absorbed orally, vaginally and across the mucous membranes of the rectum and oral cavity \[6\] \[7\] \[8\]. Misoprostol is affordable, widely available, and easily administrated via multiple routes, and has a good safety profile if properly administrated and monitored, all of which might make it the standard treatment option for PPH in low-resource settings \[9\]. The benefits (cervical dilatation and uterine contractions) and the adverse effects (nausea, vomiting, diarrhea, fever, and chills) are dose-dependent \[10\]. Hofmeyr et al. studied the pharmacokinetics of misoprostol administered by various routes. According to this study, the oral route has the most rapid uptake, but the shortest duration. The rectal route has slow uptake but prolonged duration. The buccal and sublingual routes have rapid uptake, prolonged duration and greatest total bioavailability \[11\]. Besides that, it can be used for termination of pregnancy in cases of missed or incomplete miscarriage \[12\] \[13\]. Also, in cases with retained placenta, it may have a role in the management of associated bleeding which mostly results from atony \[14\] \[15\]. In the field of gynecology, misoprostol could be used for induction of cervical ripening before office gynecological procedures \[16\] \[17\] \[18\]. This could decrease the associated pain induced by transcervical passage of instruments. Intraoperative blood loss is one of the important complications during CS. In 2011, a systematic review that included twenty-one studies revealed that there is an increased incidence of intraoperative blood loss and blood transfusion with an increased number of cesarean deliveries \[19\]. Previous reports have shown that misoprostol is effective in reducing blood loss during and after cesarean delivery regardless of route of administration \[20\] . However, the optimum time for administration of misoprostol to decrease the amount of PPH is still under discussion. A. E. A. Youssef et al. DOI: 10.4236/ojog.2019.94052 531 Open Journal of Obstetrics and Gynecology Therefore the current study aims to compare the effect of preoperative vaginal and postoperative sublingual administration of misoprostol (800 μg) in reducing the amount of blood loss during and 24 hours after CS. Cesarean section (CS) is one of the most frequently performed operative interventions worldwide \[1\]. Cesarean section rates increase each year throughout the world. Cesarean delivery can lead to some serious maternal and fetal complications \[2\] including primary postpartum hemorrhage (PPH). Primary PPH is defined as a blood loss of more than 1000 ml during the first 24 hours after delivery \[3\], and it is the most common cause of maternal mortality worldwide \[4\]. Misoprostol is a synthetic prostaglandin E1 analog, commonly used for the prevention and management of PPH. It has potent uterotonic properties and fewer side effects at therapeutic doses \[5\]; it is absorbed orally, vaginally and across the mucous membranes of the rectum and oral cavity \[6\] \[7\] \[8\]. Misoprostol is affordable, widely available, and easily administrated via multiple routes, and has a good safety profile if properly administrated and monitored, all of which might make it the standard treatment option for PPH in low-resource settings \[9\]. The benefits (cervical dilatation and uterine contractions) and the adverse effects (nausea, vomiting, diarrhea, fever, and chills) are dose-dependent \[10\]. Hofmeyr et al. studied the pharmacokinetics of misoprostol administered by various routes. According to this study, the oral route has the most rapid uptake, but the shortest duration. The rectal route has slow uptake but prolonged duration. The buccal and sublingual routes have rapid uptake, prolonged duration and greatest total bioavailability \[11\]. Besides that, it can be used for termination of pregnancy in cases of missed or incomplete miscarriage \[12\] \[13\]. Also, in cases with retained placenta, it may have a role in the management of associated bleeding which mostly results from atony \[14\] \[15\]. In the field of gynecology, misoprostol could be used for induction of cervical ripening before office gynecological procedures \[16\] \[17\] \[18\]. This could decrease the associated pain induced by transcervical passage of instruments. Intraoperative blood loss is one of the important complications during

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• the amount of blood loss

  the amount of blood loss during and 24 hours after CS

  24 hours

Study Arms (1)

CS group

ACTIVE COMPARATOR

women who will undergo elective lower segment CS at term (≥37 weeks) with normal fetal heart tracing

Drug: Misoprostol

Interventions

Misoprostol DRUG

preoperative vaginal and postoperative sublingual administration of misoprostol (800 μg) to reducing the amount of blood loss during and 24 hours after CS to determine the optimum time for drug administration.

CS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study includes women will undergo elective lower segment CS at term (≥37 weeks) with normal fetal heart tracing

You may not qualify if:

• Women with placenta previa . preterm delivery, hypertensive disorders of pregnancy, bleeding tendency, previous history of PPH, concurrent anticoagulant therapy, concurrent long-term use of steroids, fetal distress and antepartum haemorrhage will be excluded from the study

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Acharya G, Al-Sammarai MT, Patel N, Al-Habib A, Kiserud T. A randomized, controlled trial comparing effect of oral misoprostol and intravenous syntocinon on intra-operative blood loss during cesarean section. Acta Obstet Gynecol Scand. 2001 Mar;80(3):245-50. doi: 10.1034/j.1600-0412.2001.080003245.x.

  PMID: 11207490 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Ahmed Mohamed Hatem Fouad, resident doctor

CONTACT

+201025178300; ahmeddhatemm22@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Assiut University hospital

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 9, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 9, 2025

Record last verified: 2025-01