Intrauterine Misoprostol Versus Rectal Misoprostol in Reducing Blood Loss During Cesarean Section

NCT03723031 | Unknown Phase 2 DMC

• 1 other identifier: 1121980
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

98 pregnant women attending for CS will be randomized into 2 groups. Rectal misopristol group who will receive 400 microgram misoprostol rectally preoperatively with urinary catheter insertion and intrauterine misopristol group will receive 400 microgram misoprostol intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta. The estimated blood loss for each patient will be measured and data of both groups will be compared.

Conditions

Hemorrhage, Postpartum

Keywords

hemorrhage; misopristol; Cesarean section

Outcome Measures

Primary Outcomes (1)

• estimated blood loss during and after CS

  EBL= EBV x { (Preoperative hematocrit - Postoperative hematocrit) ÷ Postoperative hematocrit} Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).

  within 12 hours after delivery

Secondary Outcomes (4)

• estimated blood loss during CS

  within the CS procedure

• Use of additional ecbolics denoting uterine atony

  within CS procedure

• The occurrence of any maternal side effects (in both groups)

  within 24 hours after the CS procedure

• The occurrence of any fetal side effects (rectal group only)

  within 24 hours after the CS procedure

Study Arms (2)

rectal misopristol

ACTIVE COMPARATOR

will receive 400 microgram misoprostol rectally preoperatively with urinary catheter insertion.

Drug: Misoprostol

intrauterine misopristol

ACTIVE COMPARATOR

will receive 400 microgram misoprostol inserted intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta.

Drug: Misoprostol

Interventions

Misoprostol DRUG

400 microgram (2 tablets) misoprostol ( cytotec, Pfizer, G.D. Searle LLC) inserted rectally (before CS) in rectal group or intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta in intrauterine group.

Also known as: cytotec

intrauterine misopristol; rectal misopristol

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women candidate for CS.
• Full term singleton living pregnancies (\> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan).
• Spinal or epidural anesthesia for the CS.

You may not qualify if:

• Maternal Anemia (hemoglobin \<9 g%)
• Maternal medical disorders (e.g. cardiac, renal, and hepatic diseases, or coagulopathies).
• Fetal anomalies or IUGR (estimated fetal weight below the 5th centile)
• Risk of obstetric hemorrhage (e.g. peripartum hemorrhage, abnormal placentation, previous history of uterine atony or postpartum hemorrhage).
• Women attending for emergency CS.
• More than 2 previous CS procedures.
• Prolonged procedure (more than 2 hours from skin incision to skin closure).
• History of prostaglandin allergy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine - Cairo university

Cairo, Egypt

RECRUITING

Related Publications (1)

• El-Sherbini MM, Maged AM, Helal OM, Awad MO, El-Attar SA, Sadek JA, ElKomy R, Dawoud MA. A comparative study between preoperative rectal misoprostol and intraoperative intrauterine administration in the reduction of blood loss during and after cesarean delivery: A randomized controlled trial. Int J Gynaecol Obstet. 2021 Apr;153(1):113-118. doi: 10.1002/ijgo.13426. Epub 2020 Nov 6.

  PMID: 33064852 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine 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

Study Officials

• moutaz elsherbini, MD

  Assistant professor of obstetrics and gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

moutaz elsherbini, MD

CONTACT

(+2)01001588300; mizosherbini@yahoo.com

Mirna mohamed awad, MSc

CONTACT

(+2)01001401172; mirnaawad91.ma@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 29, 2018
• Study Start: November 15, 2018
• Primary Completion: April 15, 2020
• Study Completion: May 15, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

EG (1)