NCT03006380

Brief Summary

Randomized controlled study to assess the efficacy and safety of the timing of administration of prophylactic oxytocin via intramuscular route (before compared to after placental delivery) on blood loss in vaginal delivery.

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
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

August 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

December 22, 2016

Last Update Submit

March 13, 2017

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • blood loss in vaginal delivery

    blood loss in the third stage of labor (Up to 60 min after delivery of the baby)

Secondary Outcomes (10)

  • primary postpartum hemorrhage

    within 24 hours after delivery

  • changes in hemoglobin and hematocrit

    before delivery and after 6 hours

  • retained placenta

    more than 30 minutes after delivery

  • length of 3rd stage of labor

    Up to 60 min from delivery of baby till delivery of placenta

  • manual removal of the placenta

    if not separated after 30 minutes from delivery

  • +5 more secondary outcomes

Study Arms (2)

oxytocin before placental delivery

EXPERIMENTAL

patients who will receive 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly at delivery of anterior shoulder of the fetus and an identical placebo injection (normal saline, NACL 0.9%) intramuscularly following delivery of the placenta.

Drug: oxytocin

oxytocin after placental delivery

EXPERIMENTAL

patients who will receive placebo injection (normal saline, NACL 0.9%) intramuscularly at delivery of anterior shoulder of the fetus and 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly following delivery of the placenta.(opposite medication sequence)

Drug: oxytocin

Interventions

oxytocinDRUG

Ecbolic used to reduce blood loss

Also known as: Syntocinon®, NOVARTIS, Egypt
oxytocin after placental deliveryoxytocin before placental delivery

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Multiparous women (had previous one, up to four deliveries)
  • Term pregnancy (37 completed weeks at least).
  • Singleton viable cephalic pregnancy.
  • Vaginal delivery.

You may not qualify if:

  • Primigravida.(first pregnancy)
  • Grand multiparous. (had previous 5 or more deliveries)
  • Maternal illness (involving pregnancy induced condition; PIH,GDM or chronic medical condition; hypertension, cardiac , renal problems)
  • Previous cesarean section, uterine surgery.
  • Patients with bleeding tendency.
  • Previous history of Ante-partum hemorrhage.
  • Previous history of postpartum hemorrhage.
  • Abnormal site of the placenta (detected by ultrasound)
  • Macrosomic baby (EFW more than 4000 gm estimated clinically or by ultrasound)
  • polyhydramnios.(detected by ultrasound)
  • Multiple gestation.
  • Chorioamnionitis.
  • Suspected fetal problem(anomaly, distress)
  • Instrumental delivery.
  • Multiple or deep vaginal tears that compromise the estimation of uterine blood loss.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocinlactitol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Amr Yehia, MD, MRCOG

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Reham Marie, MRCOG

CONTACT

+201212977339rehamfarghal84@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of obstetrics and gynecology

Study Record Dates

First Submitted

December 22, 2016

First Posted

December 30, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

March 15, 2017

Record last verified: 2017-03

Locations

EG(1)