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Treatment of postpartum haemorrhage

Phase 3
Conditions
Postpartum haemorrhage (PPH)
Pregnancy and Childbirth
Registration Number
ISRCTN92079573
Lead Sponsor
World Health Organization
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
Female
Target Recruitment
6200
Inclusion Criteria

1. Had a singleton pregnancy
2. Had a vaginal birth
3. Receive HSC for PPH prophylaxis during the vaginal birth
4. Have an indication to receive uterotonics for the first response treatment of PPH presumably due to uterine atony (clinically diagnosed, or measured blood loss of 500 ml or more from the vagina, and where known coagulopathy and retained placenta has been excluded as the cause of bleeding)
5. Provided written informed consent before any trial-related procedures are carried out.

Exclusion Criteria

1. Known history of allergy to HSC or oxytocin or excipients in the medicinal products used in the trial
2. Known serious coagulopathy, epilepsy, hepatic, renal, or cardiovascular disease
3. Known intrauterine foetal death
4. Birth that is considered an abortion according to local gestational age limit
5. Other clinically significant condition(s) that, in the opinion of the investigator could represent increased health risk for the participation of the woman or interfere with the objectives of the trial
6. A manual removal of placenta
7. A placenta in-situ that has not been expelled or removed
8. Known administration of any uterotonic for PPH treatment (e.g. prostaglandins, oxytocin, ergometrine) following PPH prophylaxis.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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