Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05077540
Other study ID # aswu/543/8/21
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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,

Study Design


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
See also
  Status Clinical Trial Phase
Terminated NCT03276741 - Oral Intake During Labor N/A
Active, not recruiting NCT03199820 - Balloon Catheter Versus Propess for Labour Induction Phase 4
Active, not recruiting NCT05250960 - Pre-epidural SCDs to Prevent Hypotension During Labor N/A
Enrolling by invitation NCT05674838 - Leg Elevation to Prevent Hypotension During Labor N/A
Completed NCT03752879 - The Association Between Kristeller Maneuver and Pelvic Floor Trauma After Vaginal Delivery
Completed NCT05339399 - 4 Versus 6 cm Active Phase of Labour
Terminated NCT05175040 - PROphylactic Manual RotatIon in the Second stagE of Labor N/A
Recruiting NCT04330742 - The Effect of Fluids on Aortic VTI During C-section
Not yet recruiting NCT04009993 - A-BIRTHPERFORM Versus Conventional Partogram in the Improvement of Birth Results N/A
Not yet recruiting NCT05910359 - Ultrasound Prediction of POPP in Active Labor N/A
Recruiting NCT02853058 - Uterine Artery Pulsatility Index and Materno Fetal Outcomes N/A
Not yet recruiting NCT05791630 - The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL) N/A
Recruiting NCT04303702 - The Role of Oxytocin in the Second Stage of Labor N/A
Recruiting NCT05719467 - SAINT: Safe Induction of Labor Trial Phase 3
Completed NCT03342508 - Fetal Pillow Randomized Controlled Trial N/A
Recruiting NCT03272282 - Paperless Parotograph in Evaluation of Labour N/A
Recruiting NCT05837559 - Traditional WHO Partograph and Korle-Bu Modified WHO Partograph for Uncomplicated Labour N/A
Completed NCT06420453 - How Long Can Labor Last? Person Centred Care During Labor to Increase Safety for Women and Newborn
Recruiting NCT06261710 - Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations N/A
Completed NCT03276117 - Wide Use of Paperless Partograph in Evaluation of Labour N/A