Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section

Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section: A Double-blind Randomized Clinical Trial

This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till October 2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Drug: Misoprostol; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients booked for elective cesarean section.
• Singleton pregnancies.
• Full term pregnancies (GA 37- 42 Wks).
• Age (18-40 yrs).
• body mass index (BMI) (20-30(Kg/m2 .

Exclusion Criteria:

• Contraindication to spinal anesthesia.
• Blood dyscrasias.
• Large fibroids.
• Multiple pregnancies.
• Overdistended uterus eg. Hydramnios.
• Pre-eclampsia.
• Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl).
• Previous history of PPH.
• Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
• Placenta previa.
• Previous myomectomy.
• Extreme of BMI (<20 or >30 Kg/m2 ).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Preoperative; • Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative sublingual placebo"2 tablets".	Drug: Misoprostol; mesotac; Other: Placebo; Placebo tablet identical to the misoprostol tablet but without the active ingredient
Active Comparator: Postoperative; • Group no.2 will receive preoperative sublingual placebo "2 tablets" and postoperative sublingual 400 microgram of misoprostol (Sigma) " 2 tablets" .	Drug: Misoprostol; mesotac; Other: Placebo; Placebo tablet identical to the misoprostol tablet but without the active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Need for extra uterotonics	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative blood loss		intraoperative
postpartum hemorrhage		24 hours
neonatal outcome	measured by APGAR score at 1 and 5 minutes	5 minutes

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Actual): January 12, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: April 29, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: cesarean section; sublingual; Misoprostol; uterotonics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: AS1374

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No