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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05077540

Enrollment

150

Registered

2021-10-14

Start date

2021-11-01

Completion date

2023-12-31

Last updated

2021-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Complication

Brief 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 .

Detailed 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.

Interventions

DRUGoxytocin

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

DRUGmisoprostol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double-blinded a randomized controlled trial

Intervention model description

double-blinded a randomized controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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,

Design outcomes

Primary

Measure	Time frame	Description
measured excessive bleeding blood loss ≥ 300 mills after PPH treatment	24 hours	measured amount of blood loss ≥ 300 mills after PPH treatment

Secondary

Measure	Time frame	Description
change in hemoglobin	12 hours	measure change of hemoglobin
need for additional interventions	24 hours	number of patients need additional interventions ,like uterine aetry ligation

Contacts

Primary Contacthany f sallam, md

hany.farouk@aswu.edu.eg+201112501460

Backup Contactnahla w waer, md

nahlagyn@yahoo.com+201022336052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026