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Carbetocin Versus Misoprostol in Cases With Placenta Previa After C.S.

Carbetocin Versus Misoprostol for Prevention of Postpartum Hemorrhage in Cases With Placenta Previa After C.S.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02277041
Acronym
PPH
Enrollment
200
Registered
2014-10-28
Start date
2014-10-31
Completion date
2021-04-30
Last updated
2021-02-02

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

Conditions

Postpartum Hemorrhage

Keywords

PPH

Brief summary

We will compare efficacy and safety of Carbetocin with Misoprostol in prevention of postpartum hemorrhage in Placenta previa women after C.S.

Detailed description

Postpartum hemorrhage was traditionally defined as blood loss in excess of 500 mL from a vaginal delivery or 1000 mL at cesarean section. It can result from uterine atony, retained placental tissue including that from abnormal placentation, maternal genital tract trauma and coagulopathies. (Almog et al, 2011) * Uterotonic agents (e.g. ergometrine, misoprostol) should be easily accessible. Many units of an oxytocin infusion and/or rectal misoprostol during and after cesarean deliveries used to reduce the incidence of atony. -Misoprostol has been widely recommended for the prevention of post-partum hemorrhage when other methods are not available. The most common regimen reported for the treatment of post-partum hemorrhage is rectally. (Oladapo et al., 2012) * Misoprostol is a prostaglandin E1 analogue. It has been investigated in the prevention of postpartum hemorrhage, using either the oral or rectal route of administration. (Hofmeyr et al, 2009) * Carbetocin is a long-acting oxytocin studied by Dansereau et al.; 1999.They found that the carbetocin group of patients had a decreased incidence of PPH and of the need for therapeutic oxytocics. The recommended dose of carbetocin is 100 mg given either IM or slowly (over 1 minute). * Placenta previa, placenta accreta, and vasa previa are important causes of bleeding in the second half of pregnancy and in labor. Risk factors for placenta previa include prior cesarean delivery, pregnancy termination, intrauterine surgery, smoking, multifetal gestation, increasing parity, and maternal age. Thus, placenta previa is a risk factor for post partum hemorrhage.2006 Apr;107(4):927-41. Placenta previa, placenta accreta, and vasa previa. Oyelese Y1, Smulian JC.Obstet Gynecol

Interventions

DRUGCarbetocin

Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute

DRUGMisoprostol

600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.

Sponsors

Cairo University
CollaboratorOTHER
Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Women with a singleton pregnancy undergoing cesarean section after 37 weeks of gestation.

Exclusion criteria

* • Women undergoing caesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only. * women undergoing caesarean section at less than 37 weeks of gestation. * Hypertension with pregnancy. * Cardiac and coronary diseases with pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Uterine tone and sizeOne hour after the cesarean sectionThe uterine tone and size will be assessed by using a hand resting on the fundus and palpating the anterior wall of the uterus one hour after the operation. The presence of a boggy uterus with either heavy vaginal bleeding or increasing uterine size can suspect diagnosis of uterine atony.

Secondary

MeasureTime frameDescription
Blood lossOne hour after cesarean sectionBlood loss will be estimated postoperatively by giving each woman of each group standard 2 dressings (standard weight of dressing is 25 gm) for one hour postoperative and recording weight of blood soaked dressings and volume of lost blood.

Other

MeasureTime frameDescription
Hemoglobin concentrationBefore and 24 hours after the operationChanges in hemoglobin concentrations before and 24 hours postoperative. Using a 10% fall in hematocrit value to define post-partum hemorrhage.

Countries

Egypt

Contacts

Primary ContactNesreen A Shehata, MD
nesoomar@yahoo.com00201227866337
Backup ContactAbdelgany M Hassan
abdelgany2@gmail.com00201017801604

Outcome results

None listed

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