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Completed

NCT Number: NCT03148717

Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section

This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of misoprostol.

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

Neonatal Outcome

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

Exclusion Criteia:

  • Contraindication to spinal anesthesia.
  • Blood dyscrasias.
  • Large fibroids.
  • Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
  • Emergency CS such as fetal distress
  • Extreme of BMI (<20 or >30 Kg/m2 ).

Treatment and study plan

Misoprostol

Drug

Cytotec

Other names: Mesotac

Placebo

Other

Placebo tablet similar in shape, odour and consistency to misoprostol tablet.

Primary outcomes

  1. Neonatal outcome

    Time frame: 5 minutes

    measured by APGAR score at 5 minutes

Secondary outcomes

  1. NICU admission

    Time frame: 24 hours

    Number of neonates admitted to NICU within 24 hours.

  2. amount of blood loss

    Time frame: 24 hours

  3. Postpartum hemorrhage

    Time frame: 24 hours

  4. Need for extra uterotonics

    Time frame: 24 hours

Other outcomes

  1. APGAR score at 1 minute

    Time frame: 1 minute

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section: A Randomized, Double Blind Clinical Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 11, 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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