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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03144401
Other study ID # AS1374
Secondary ID
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
Health authority
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 ).

Study Design


Related Conditions & MeSH terms


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
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