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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02086994
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : February 15, 2017
Information provided by (Responsible Party):
khalid abd aziz mohamed, Benha University

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Carbetocin in Preventing Postpartum Bleeding in Women With Severe Preeclampsia.
Study Start Date : March 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol [ Time Frame: 24 hours after delivery ]
    prevention of postpartum haemorrhage

Secondary Outcome Measures :
  1. measurement of blood loss during second stage of labour [ Time Frame: 24 hours after delivery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 42 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02086994

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Benha univesity hospital
Benha, Egypt, 13518
Sponsors and Collaborators
khalid abd aziz mohamed
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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
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Responsible Party: khalid abd aziz mohamed, lecturer, Benha University Identifier: NCT02086994    
Other Study ID Numbers: khalid77
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Keywords provided by khalid abd aziz mohamed, Benha University:
carbetocin, misoprostol, pre-eclampsia, pph
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Pregnancy Complications
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents