Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section

Neonatal Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148717
• Other study ID #: AS1380
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 29, 2017
• Last updated: March 21, 2018
• Start date: May 10, 2017
• Est. completion date: March 20, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 20, 2018
• Est. primary completion date: March 2, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Patients candidate for cesarean section.

2. Full term pregnancies (GA 37- 42 Wks).

3. Age (18-40 yrs).

4. body mass index (BMI) (20-30(Kg/m2 .

Exclusion Criteia:

1. Contraindication to spinal anesthesia.

2. Blood dyscrasias.

3. Large fibroids.

4. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.

5. Emergency CS such as fetal distress

6. Extreme of BMI (<20 or >30 Kg/m2 ).

Related Conditions & MeSH terms

• Neonatal Outcome

Intervention

Drug:
• Misoprostol
Cytotec

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

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
Other	APGAR score at 1 minute		1 minute
Primary	Neonatal outcome	measured by APGAR score at 5 minutes	5 minutes
Secondary	NICU admission	Number of neonates admitted to NICU within 24 hours.	24 hours
Secondary	amount of blood loss		24 hours
Secondary	Postpartum hemorrhage		24 hours
Secondary	Need for extra uterotonics		24 hours