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

This study has been completed.
Information provided by (Responsible Party):
khalid abd aziz mohamed, Benha University Identifier:
First received: March 5, 2014
Last updated: November 25, 2015
Last verified: November 2015
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

Condition Intervention Phase
Severe Pre-eclampsia, Postpartum Condition or Complication
Drug: misoprostol
Drug: carbetocin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Carbetocin in Preventing Postpartum Bleeding in Women With Severe Preeclampsia.

Resource links provided by NLM:

Further study details as provided by Benha University:

Primary Outcome Measures:
  • Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol [ Time Frame: 24 hours after delivery ] [ Designated as safety issue: Yes ]
    prevention of postpartum haemorrhage

Secondary Outcome Measures:
  • measurement of blood loss during second stage of labour [ Time Frame: 24 hours after delivery ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: March 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cabetocin
a single dose of carbetocin (100 μg in 1 mL ampoule, Pabal) given intravenously after delivery of anterior shoulder
Drug: carbetocin
given after delivery of anterior shoulder
Other Name: pabal
Active Comparator: misoprostol
misoprostol (600 μg, 3 tables) sublingually after the delivery of the anterior shoulder of the baby.
Drug: misoprostol
given after the delivery of the anterior shoulder of the baby.
Other Names:
  • misoprost
  • cytotec
  • misotec

  Show Detailed Description


Ages Eligible for Study:   19 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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:

    1. Persistent cerebral or visual disturbances or cerebral edema.
    2. Persistent epigastric pain with nausea or vomiting, or both.
    3. Systolic ≥160 mmHg or diastolic ≥110 mmHg on 2 occasions at least 6 h apart with the patient at bed rest.
    4. Proteinuria of ≥5 g on 24-hour urine collection. Urine dipsticks are not accurate for this purpose.
    5. Oliguria (˂500 mL in 24 hours).
    6. Pulmonary edema.
    7. Thrombocytopenia.

Exclusion Criteria:

  • were HELLP syndrome, eclampsia, abruptio placentae, malpresentation, polyhydramnios, previous uterine scar, chorioamnionitis and multiple pregnancies
  Contacts and Locations
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Please refer to this study by its identifier: NCT02086994

Benha univesity hospital
Benha, Egypt, 13518
Sponsors and Collaborators
khalid abd aziz mohamed
Study Chair: khalid mohamed, MD lecturer of ob/gyn Benha faculty of medicine
Principal Investigator: ahmed sasd, MD lecturer
Principal Investigator: ahmed walid assistant profossor
  More Information

No publications provided

Responsible Party: khalid abd aziz mohamed, lecturer, Benha University Identifier: NCT02086994     History of Changes
Other Study ID Numbers: khalid77
Study First Received: March 5, 2014
Last Updated: November 25, 2015
Health Authority: Egypt: Ministry of Higher Education

Keywords provided by Benha University:
carbetocin, misoprostol, pre-eclampsia, pph

Additional relevant MeSH terms:
Puerperal Disorders
Hypertension, Pregnancy-Induced
Pregnancy Complications
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on November 30, 2015