NCT04401839

Brief Summary

The patients were divided randomly in to 2 GROUPS:

  • control group: 153 patients received Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby according to the WHO recommendation for both groups in prevention of postpartum haemorrhage,followed by active management of the third stage of labor by administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)
  • study group:156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin is stopped and cervical traction (Amr maneuver )is applied.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

May 31, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

May 21, 2020

Last Update Submit

February 5, 2021

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • postpartum hemorrhage

    blood loss more than 500 cc after delivery

    24 hours after delivery

Study Arms (2)

Control group

ACTIVE COMPARATOR

153 patients received Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby according to the WHO recommendation for both groups in prevention of postpartum haemorrhage,followed by active management of the third stage of labor by administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)

Drug: Oxytocin IV shotDrug: Oxytocin IV drip

Study group

ACTIVE COMPARATOR

156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin is stopped and cervical traction (Amr maneuver )is applied.

Drug: Oxytocin IV shotProcedure: Amr maneuver

Interventions

Oxytocin IV shotDRUG

Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby

Control groupStudy group
Oxytocin IV dripDRUG

administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation

Control group
Amr maneuverPROCEDURE

sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds

Study group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women who candidate for vaginal delivery at casualty department singleton fetus full term pregnancy ( gestational age of more than 37 weeks).

You may not qualify if:

  • fetal macrosomia, any case with bleeding tendency e.g: haemorrhagic diseases cases with risk of postpartum haemorrhage as: Peripartun hemorrhage ( placenta previa or placental abruption), anemia or hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 26, 2020

Study Start

May 31, 2020

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)