Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section

A

Ain Shams University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Cesarean Section

Treatments

Drug: Misoprostol
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03144401
AS1374

Details and patient eligibility

About

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.

Enrollment

240 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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 ).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

240 participants in 2 patient groups

Preoperative
Active Comparator group
Description:
• Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative sublingual placebo"2 tablets".
Treatment:
Other: Placebo
Drug: Misoprostol
Postoperative
Active Comparator group
Description:
• Group no.2 will receive preoperative sublingual placebo "2 tablets" and postoperative sublingual 400 microgram of misoprostol (Sigma) " 2 tablets" .
Treatment:
Other: Placebo
Drug: Misoprostol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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