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

NCT03556852 | Completed Phase 4 DMC

• 1 other identifier: 38
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• prevention of post partum hemorrhage after vaginal delivery

  Number of participants experienced postpartum hemorrhage

  24 hours after delivery

Secondary Outcomes (1)

• drugs side effects

  24 hours after delivery

Study Arms (2)

CARBETOCIN

ACTIVE COMPARATOR

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

Drug: Carbetocin

MISOPROSTOL

ACTIVE COMPARATOR

received 4 rectal misoprostol tablets (800 μg) after the delivery of the baby.

Drug: Misoprostol

Interventions

Carbetocin DRUG

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

CARBETOCIN

Misoprostol DRUG

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

MISOPROSTOL

Eligibility Criteria

• Age: 18 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• singleton pregnancy 36-40 weeks of gestation vertex presentation. normotensive hemoglobinlevel \> 10 gm/dl
• Noncomplicated pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

Related Publications (1)

• Maged AM, Waly M, Fahmy RM, Dieb AS, Essam A, Salah NM, Hussein EA, Nabil H. Carbetocin versus rectal misoprostol for management of third stage of labor among women with low risk of postpartum hemorrhage. Int J Gynaecol Obstet. 2020 Feb;148(2):238-242. doi: 10.1002/ijgo.13056. Epub 2019 Dec 2.

  PMID: 31736069 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin; Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Ahmed Maged

  professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: July 2, 2018
• Primary Completion: May 24, 2019
• Study Completion: May 30, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-10

Locations

EG (1)