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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
khalid abd aziz mohamed, Benha University
ClinicalTrials.gov Identifier:
NCT02086994
First received: March 5, 2014
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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:
  • Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol [ Time Frame: 24 hours after delivery ] [ Designated as safety issue: Yes ]
    use of additional uterotonics,

  • Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol [ Time Frame: 24 hours after delivery ] [ Designated as safety issue: Yes ]
    need for blood transfusion

  • Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol [ Time Frame: 24 hours after delivery ] [ Designated as safety issue: Yes ]
    maternal adverse drug reaction,

  • Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol [ Time Frame: 24 hours after delivery ] [ Designated as safety issue: Yes ]
    maternal complications and maternal death


Enrollment: 120
Study Start Date: March 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02086994

Locations
Egypt
Benha univesity hospital
Benha, Egypt, 13518
Sponsors and Collaborators
khalid abd aziz mohamed
Investigators
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
ClinicalTrials.gov Identifier: NCT02086994     History of Changes
Other Study ID Numbers: khalid77
Study First Received: March 5, 2014
Last Updated: September 5, 2014
Health Authority: Egypt: Ministry of Higher Education

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

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Puerperal Disorders
Hypertension, Pregnancy-Induced
Pregnancy Complications
Carbetocin
Misoprostol
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014