Prevention of Postpartum Hemorrhage in Patients With Severe Preeclampsia Using Carbetocin Versus Misoprostol

NCT02086994 | Completed Phase 3 DMC

• 1 other identifier: khalid77
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to compare carbetocin with misoprostol for the prevention of postpartum hemorrhage in patients with severe preeclampsia. The primary outcome is postpartum haemorrhage (blood loss of ≥ 500 ml) while our Secondary outcomes include use of additional uterotonics, need for blood transfusion, maternal adverse drug reaction, maternal complications and maternal death

Conditions

Severe Pre-eclampsia, Postpartum Condition or Complication

Keywords

carbetocin, misoprostol, pre-eclampsia, pph

Outcome Measures

Primary Outcomes (1)

• Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol

  prevention of postpartum haemorrhage

  24 hours after delivery

Secondary Outcomes (1)

• measurement of blood loss during second stage of labour

  24 hours after delivery

Study Arms (2)

cabetocin

ACTIVE COMPARATOR

a single dose of carbetocin (100 μg in 1 mL ampoule, Pabal) given intravenously after delivery of anterior shoulder

Drug: carbetocin

misoprostol

ACTIVE COMPARATOR

misoprostol (600 μg, 3 tables) sublingually after the delivery of the anterior shoulder of the baby.

Drug: misoprostol

Interventions

misoprostol DRUG

given after the delivery of the anterior shoulder of the baby.

Also known as: misoprost, cytotec, misotec

misoprostol

carbetocin DRUG

given after delivery of anterior shoulder

Also known as: pabal

cabetocin

Eligibility Criteria

• Age: 19 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with singleton pregnancies of more than 28 weeks' gestation who were admitted to hospital with severe preeclampsia and candidates for vaginal delivery were eligible for the study. Preeclampsia is labelled as severe in the presence of any of the following abnormalities:
• Persistent cerebral or visual disturbances or cerebral edema.
• Persistent epigastric pain with nausea or vomiting, or both.
• Systolic ≥160 mmHg or diastolic ≥110 mmHg on 2 occasions at least 6 h apart with the patient at bed rest.
• Proteinuria of ≥5 g on 24-hour urine collection. Urine dipsticks are not accurate for this purpose.
• Oliguria (˂500 mL in 24 hours).
• Pulmonary edema.
• Thrombocytopenia.

You may not qualify if:

• were HELLP syndrome, eclampsia, abruptio placentae, malpresentation, polyhydramnios, previous uterine scar, chorioamnionitis and multiple pregnancies

Sponsors & Collaborators

• khalid abd aziz mohamed: lead

Study Sites (1)

Benha univesity hospital

Banhā, 13518, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia; Familial Primary Pulmonary Hypertension

Interventions

Misoprostol; carbetocin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• khalid mohamed, MD

  lecturer of ob/gyn Benha faculty of medicine

  STUDY CHAIR

• ahmed sasd, MD

  lecturer

  PRINCIPAL INVESTIGATOR

• ahmed walid

  assistant profossor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 14, 2014
• Study Start: March 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 15, 2017

Record last verified: 2017-02

Locations

EG (1)