Comparative Study Between Oxytocin Infusion Before and After Placental Delivery on Blood Loss During and After Cesarean Delivery .

NCT ID: NCT06889155

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2024-09-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intraoperative Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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oxytocin before placental delivery

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.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

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 delivery

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.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

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

Interventions

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Oxytocin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Maged, MD

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Armed force faculty of medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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110

Identifier Type: -

Identifier Source: org_study_id

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