Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144401
• Other study ID #: AS1374
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 29, 2017
• Last updated: March 21, 2018
• Start date: April 10, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: March 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 1, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 ).

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Drug:
• Misoprostol
mesotac

Other:
• Placebo
Placebo tablet identical to the misoprostol tablet but without the active ingredient

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for extra uterotonics		24 hours
Secondary	intraoperative blood loss		intraoperative
Secondary	postpartum hemorrhage		24 hours
Secondary	neonatal outcome	measured by APGAR score at 1 and 5 minutes	5 minutes