NCT03390010

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

December 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2018

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

December 28, 2017

Last Update Submit

November 11, 2022

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • The number of participants who passed cesarean section without postpartum hemorage

    within 2 days post CS

Study Arms (2)

Extra medication group

ACTIVE COMPARATOR

-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 management of labour group

ACTIVE COMPARATOR

* 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

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

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
Extra medication group
Syntocinon and using extra uterotonic drugs when needed ; methergine carboprostDRUG

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
Active management of labour group

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah

Giza, Egypt

Location

MeSH Terms

Interventions

MisoprostolOxytocinMethylergonovineCarboprostPharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsErgonovineErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingProstaglandins F, Synthetic

Study Officials

  • Mahmoud Alalfy, M.s.c

    Algazeerah hospital -Location (Giza -Egypt )

    STUDY CHAIR

  • yossra Lasheen, M.D

    kasraliny hospital- Aljazeerah hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 4, 2018

Study Start

December 28, 2017

Primary Completion

February 28, 2018

Study Completion

March 6, 2018

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)