Current partner codePEPTIDESDE
NCT02277041·Phase 4·INTERVENTIONAL

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

Status

Unknown

Phase

Phase 4

Enrollment

200

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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

Treatment arms and agents.

DRUG

Carbetocin

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

DRUG

Misoprostol

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

Timeline

From registration to results.

  1. First posted

    Oct 28, 2014

  2. Study start

    Oct 2014

  3. Primary completion

    Apr 2021

  4. Study completion

    Apr 2021

  5. Results posted

    Not reported

  6. Registry updated

    Feb 2, 2021

Outcomes

What the study measures.

Primary outcomes

Uterine tone and size

Time frame · One hour after the cesarean section

The 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 outcomes

Blood loss

Time frame · One hour after cesarean section

Blood 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.

Eligibility

Who can take part.

Minimum age
25 Years
Maximum age
40 Years
Sex
FEMALE
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

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Beni-Suef University

Cairo, Egypt

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.