Misoprostol Versus Active Management of Labour in CS

Phase 1

Completed

• Conditions: Cesarean Section
• Interventions: Drug: Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine; Drug: Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost

• Registration Number: NCT03390010
• Lead Sponsor: Aljazeera Hospital

Brief Summary

Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing maternal morbidity and mortality .

Detailed Description

Many approved drugs are used in prophylaxis against postpartum hemorage from these medications are the (syntocinon combined with methergine ) that are known as active management of labour drugs .

Moreover there is misotac , that also guards against postpartum hemorage .

All these medications act in a different way to cause uterine contraction post delivery to prevent uterine atony .

-Here we are comparing the additive value of misotac intrauterine to syntocinon and methergine in comparison to the usually used syntocinon plus methergine .

Study Timeline

• Study Start: 2017-12-28
• Study First Submitted: 2017-12-28
• Study First Submitted QC: 2017-12-28
• Study First Posted: 2018-01-04
• Primary Completion: 2018-02-28
• Study Completion: 2018-03-06
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-11
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• • All patients included in this research were aged 18-42 years, pregnant 37 weeks till 42 weeks

  • no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to full history taking, examination.

Exclusion Criteria

• Exclusion Criteria:

  • The following patients were excluded , GA before 37 weeks or after 42 weeks , medical disorders with pregnancy eg. DM with pregnancy, HTN with pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extra medication group	Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine	-Procedure : Giving misoprostol plus syntocinon during CS this group in which prevention of uterine atony is made by intrauterine misoprostol plus the usual syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost
Active management of labour group	Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost	* Procedure: Giving syntocinon during cesarean section * this group in which prevention of uterine atony is made by the usual active management of labour syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost

Primary Outcome Measures

Name	Time	Method
The number of participants who passed cesarean section without postpartum hemorage	within 2 days post CS

Trial Locations

Locations (1)

Algazeerah; 🇪🇬 Giza, Egypt