NCT06889155

Brief Summary

Participants were randomized using computer-generated random numbers into 2 groups. Group I included 32 women who received oxytocin infusion before placental delivery just after cord clamping and group II included 32 women who received oxytocin infusion after placental delivery. In both groups 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

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

Study Start

First participant enrolled

August 30, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

March 17, 2025

Last Update Submit

March 17, 2025

Conditions

Intraoperative Blood Loss

Outcome Measures

Primary Outcomes (1)

  • Intraoperative blood loss

    This was measured by weighing the surgical sponges and the suction canisters used during the procedure

    during cesarean delivery

Study Arms (2)

oxytocin before placental delivery

ACTIVE COMPARATOR

oxytocin infusion before placental delivery just after cord clamping 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.

Drug: Oxytocin

oxytocin after placental delivery

ACTIVE COMPARATOR

oxytocin infusion after placental delivery 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.

Drug: Oxytocin

Interventions

OxytocinDRUG

10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.

oxytocin after placental deliveryoxytocin before placental delivery

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 - 40 years
  • singleton full term pregnancy.
  • Candidate for elective cesarean delivery under spinal anaesthesia

You may not qualify if:

  • women at high risk for intraoperative bleeding as those with placenta previa or other placental abnormalities
  • women with bleeding or coagulation disorders.
  • Medical disorder associating pregnancy as preeclampsia or diabetes
  • Allergy or contraindications to oxytocin
  • Fetal macrosomia, or congenital anomalies
  • Polyhydramnios
  • Uterine abnormalities as fibroids
  • Women with intraoperative complications as vascular or visceral injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed force faculty of medicine

Cairo, 12111, Egypt

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ahmed Maged, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 21, 2025

Study Start

August 30, 2023

Primary Completion

May 27, 2024

Study Completion

September 14, 2024

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations

EG(1)