NCT06217354CompletedPhase 1/2
Efficacy of Carbetocin in Prevention of Postpartum Hemorrhage in Obese Versus Non Obese Women
Efficacy of Carbetocin at Elective Cesarean Section in Prevention of Postpartum Hemorrhage in Obese Versus Non-obese Women, A Randomized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 22 Jan 2024
Brief summary (registry, in English)
Postpartum hemorrhage \[PPH\] can have serious consequences and is the leading cause of maternal mortality globally. Uterine contractility plays an important role in post-delivery uterine involution; impaired contractility can contribute to PPH. Should contractility be impaired among obese women, there would be implications for management. Therefore, the investigators sought to investigate whether obese women would also experience a need for more uterine agents during the management of an obstetric hemorrhage.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 10 Dec 2023
- Start date
- 6 Jul 2023
- Primary completion date
- 25 Oct 2023
- Lead sponsor
- Cairo University
- Diseases
- Obesity
- NCT number
- NCT06217354
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 150
- From 6 Jul 2023 to the primary completion date, 25 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Maternal comorbidities such as severe cardiovascular disorders, kidney or liver disorders, coagulopathies, as well as epilepsy.
- Known hypersensitivity to carbetocin or oxytocin.
Other
- Emergency Cesarean Section due to fetal distress.
- Uterine malformation.
- Fetal malformation.
- Uterine overdistention (as in polyhydramnios, twins, and fetal macrosomia)
- Injury of uterine vessels during CS.
Who the study is looking for
- Healthy women with a singleton pregnancy undergoing a Cesarean delivery after at least 37 completed weeks of gestation under regional anesthesia.
- Aged (18-39) years and with signed informed consent.
Age in the registry: 18 years to 39 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shaimaa El Shemy Coordinator of this site? Confirm its status | Giza | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.