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CompletedNCT03390010Updated Nov 16, 2022

Misoprostol Versus Active Management of Labour in CS

A Phase 1 interventional study of Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine and Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost in Cesarean Section, sponsored by Aljazeera Hospital. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-16.

Sponsored by Aljazeera Hospital · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 42 Years
Sex
Female
01

Study summary

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

Read the 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 .

02

Conditions studied

  • Cesarean Section
03

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

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
04

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • Active comparator
    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

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

  • Active comparator
    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

    Drug: Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost

Interventions

  • DrugMisoprostol + 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

    Also known as: DrugsMisoprostol plus syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost

  • DrugSyntocinon 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

    Also known as: drugs ( syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost

05

What researchers measure

Primary outcomes

  1. The number of participants who passed cesarean section without postpartum hemorage

    Time frame: within 2 days post CS

06

Study locations

1 site
  • Algazeerah
    Giza, Egypt
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03390010
Lead sponsor
Aljazeera Hospital
Collaborators
Cairo University
Responsible party
Sponsor
First posted
Jan 4, 2018
Start date
Dec 28, 2017
Primary completion
Feb 28, 2018
Completion
Mar 6, 2018
Last update
Nov 16, 2022

Study contacts

Mahmoud Alalfy, M.s.c
study chair · Algazeerah hospital -Location (Giza -Egypt )
yossra Lasheen, M.D
principal investigator · kasraliny hospital- Aljazeerah hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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