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NCT Number: NCT03144401

Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section

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.

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Key information

Conditions

Cesarean Section

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ).

Treatment and study plan

Misoprostol

Drug

mesotac

Placebo

Other

Placebo tablet identical to the misoprostol tablet but without the active ingredient

Primary outcomes

  1. Need for extra uterotonics

    Time frame: 24 hours

Secondary outcomes

  1. intraoperative blood loss

    Time frame: intraoperative

  2. postpartum hemorrhage

    Time frame: 24 hours

  3. neonatal outcome

    Time frame: 5 minutes

    measured by APGAR score at 1 and 5 minutes

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 8, 2017
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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