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

Labor Complication Clinical Trial

Official title:

The Effect of Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05077540
• Other study ID #: aswu/543/8/21
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2021
• Source: Aswan University Hospital
• Contact: hany f sallam, md
• Phone: +201112501460
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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,

Related Conditions & MeSH terms

• Hemorrhage
• Labor Complication
• Obstetric Labor Complications
• Postpartum Hemorrhage

Intervention

Drug:
• oxytocin
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measured excessive bleeding blood loss = 300 mills after PPH treatment	measured amount of blood loss = 300 mills after PPH treatment	24 hours
Secondary	change in hemoglobin	measure change of hemoglobin	12 hours
Secondary	need for additional interventions	number of patients need additional interventions ,like uterine aetry ligation	24 hours