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Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery

NCT ID: NCT05077540

Last Updated: 2021-10-22

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-12-31

Brief Summary

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Researchers sought to see how oxytocin versus, sublingual misoprostol affected estimated and measured blood loss during vaginal delivery in women who had blood loss \>300 ml .

Detailed Description

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The greatest cause of maternal mortality globally is postpartum hemorrhage (PPH), which is defined as a blood loss of 500 mL or more after birth. All women giving birth should be given a preventive uterotonic drug, according to the World Health Organization (WHO).

Despite the use of a uterotonic drug as a preventative measure, PPH remains a frequent complication, accounting for one-quarter of all maternal fatalities worldwide. When prophylaxis fails and PPH develops, it is advised that uterotonic medicines be used as first-line therapy. However, it's unclear whether the uterotonic drug is better for treating PPH as first-line therapy.

Conditions

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Labor Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double-blinded a randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
double-blinded a randomized controlled trial

Study Groups

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oxytocin

20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)

Group Type ACTIVE_COMPARATOR

oxytocin

Intervention Type DRUG

20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)

misoprostol

800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)

Group Type EXPERIMENTAL

misoprostol

Intervention Type DRUG

800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)

Interventions

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oxytocin

20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)

Intervention Type DRUG

misoprostol

800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)

Intervention Type DRUG

Other Intervention Names

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Active Comparator Active Comparator

Eligibility Criteria

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Inclusion Criteria

* vaginal birth in women who had blood loss \>300 ml

Exclusion Criteria

* \<37 weeks of pregnancy,
* genital tract injuries,
* coagulation deficit,
* hypertension, preeclampsia,
* cardiac, renal, or hepatic disease,
* epilepsy,
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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hany farouk

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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hany f sallam, md

Role: CONTACT

[email protected]
+201112501460 ext. 002

nahla w waer, md

Role: CONTACT

[email protected]
+201022336052 ext. 002

Other Identifiers

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aswu/543/8/21

Identifier Type: -

Identifier Source: org_study_id