A Trial of Sublingual Misoprostol to Reduce Primary Postpartum Haemorrhage After Vaginal Delivery

NCT05079061 | Unknown Phase 4 FDA Drug

• 1 other identifier: UW 20-044
• Study Type: interventional
• Target: 1,300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the randomized controlled study is to compare combination of sublingual misoprostol and routine uterotonics versus routine uterotonics alone on PPH in low risk women after vaginal delivery. The hypothesis is that combination of sublingual misoprostol and routine uterotonics is more effective than routine uterotonics alone in reduction of PPH in low risk women after vaginal delivery.

Conditions

Primary Postpartum Hemorrhage; Misoprostol; Delivery Complication

Outcome Measures

Primary Outcomes (1)

• Percentage of primary postpartum haemorrhage

  blood loss 500ml or more at delivery

  within first 24 hours after delivery

Secondary Outcomes (12)

• Percentage of severe postpartum haemorrhage

  within first 24 hours after delivery

• Percentage of need for additional uterotonics for treatment of postpartum haemorrhage

  within first 24 hours after delivery

• Duration of third stage of labour

  within first 24 hours after delivery

• Percentage of need for manual removal of placenta

  within first 24 hours after delivery

• Incidence of uterine atony

  within first 24 hours after delivery

Study Arms (2)

Misoprostol group

ACTIVE COMPARATOR

At delivery of baby, routine uterotonics (syntometrine 1ml intramuscular or syntocinon 5 units intravenous bolus followed by 40 units in 500ml normal saline infusion over 4 hours in women contraindicated for syntometrine) will be given as routine practice, and sublingual misoprostol will be given to women in misoprostol group.

Drug: Misoprostol

Control group

NO INTERVENTION

At delivery of baby, routine uterotonics (syntometrine 1ml intramuscular or syntocinon 5 units intravenous bolus followed by 40 units in 500ml normal saline infusion over 4 hours in women contraindicated for syntometrine) will be given as routine practice, and no additional sublingual misoprostol will be given to women in control group.

Interventions

Misoprostol DRUG

sublingual misoprostol 600 micrograms in addition routine uterotonics at third stage of labour

Also known as: cytotec

Misoprostol group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women age ≥ 18 years (age of legal consent)
• Singleton pregnancy \>= 34 weeks

You may not qualify if:

• Women planning for Caesarean section
• Women with known risk factors for PPH, including grand multiparity (\>=4), multiple pregnancy, fibroid with size \>4cm, history of PPH, placenta previa, large-for-gestational age fetus (defined as EFW \>90th centile), polyhydramnios, and previous Caesarean section.
• Women with bleeding tendency or thrombocytopenia \< 100 x 109/L
• Women on anticoagulant or aspirin
• Women in whom use of misoprostol / syntocinon / syntometrine is contraindicated
• Women with known hypersensitivity to misoprostol / syntocinon / syntometrine

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Diana Man Ka Chan, MBBS

  Department of Obstetrics & Gynaecology, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Man Ka Chan, MBBS

CONTACT

(852) 2255 4517; dcmanka@gmail.com

Yin Kwan Mok, MBBS

CONTACT

(852) 2255 4517; sophiamok1123@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate consultant

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: October 15, 2021
• Study Start: April 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share