Misoprostol Versus Active Management of Labour in CS

NCT ID: NCT03390010

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-28

Study Completion Date

2018-03-06

Brief Summary

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

Detailed Description

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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 .

Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Extra medication group

-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

Group Type ACTIVE_COMPARATOR

Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine

Intervention Type DRUG

medical prophylaxis against postpartum atony and postpartum hemorage by giving misoprostol plus syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost

Active management of labour group

* 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

Group Type ACTIVE_COMPARATOR

Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost

Intervention Type DRUG

medical prophylaxis against postpartum atony and postpartum hemorage by giving syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost

Interventions

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Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine

medical prophylaxis against postpartum atony and postpartum hemorage by giving misoprostol plus syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost

Intervention Type DRUG

Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost

medical prophylaxis against postpartum atony and postpartum hemorage by giving syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost

Intervention Type DRUG

Other Intervention Names

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DrugsMisoprostol plus syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost drugs ( syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost

Eligibility Criteria

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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

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

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Aljazeera Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmoud Alalfy, M.s.c

Role: STUDY_CHAIR

Algazeerah hospital -Location (Giza -Egypt )

yossra Lasheen, M.D

Role: PRINCIPAL_INVESTIGATOR

kasraliny hospital- Aljazeerah hospital

Locations

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Algazeerah

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Active management of labour

Identifier Type: -

Identifier Source: org_study_id

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