Current partner codePEPTIDESDE
NCT03556852·Phase 4·INTERVENTIONAL

CARBETOCIN VERSUS RECTAL MISOPROSTOL FOR MANAGEMENT OF THIRD STAGE OF LABOR IN WOMEN AT LOW RISK OF POSTPARTUM HEMORRHAGE

Status

Completed

Phase

Phase 4

Enrollment

150

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery

Full detailed description

150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery

Interventions

Treatment arms and agents.

DRUG

Carbetocin

1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby

DRUG

Misoprostol

2 rectal misoprostol tablets (800 μg) after the delivery of the baby.

Timeline

From registration to results.

  1. First posted

    Jun 14, 2018

  2. Study start

    Jul 2, 2018

  3. Primary completion

    May 24, 2019

  4. Study completion

    May 30, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Oct 11, 2019

Outcomes

What the study measures.

Primary outcomes

prevention of post partum hemorrhage after vaginal delivery

Time frame · 24 hours after delivery

Number of participants experienced postpartum hemorrhage

Secondary outcomes

drugs side effects

Time frame · 24 hours after delivery

Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
39 Years
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria: singleton pregnancy 36-40 weeks of gestation vertex presentation. normotensive hemoglobinlevel \> 10 gm/dl • Noncomplicated pregnancy Exclusion Criteria: * Women with history of Postpartum hemorrhage in previous deliveries uterine fibroids previous cesarean section medical disorders (e.g. diabetes, anemia, coagulation disorders, cardiac, hepatic and renal diseases) antepartum hemorrhage

Study locations

1 registered sites.

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

Kasr Alainy medical school

Cairo, Egypt

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.