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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Carbetocin in Preventing Postpartum Bleeding in Women With Severe Preeclampsia.

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

Detailed Summary:

We conducted a prospective non-randomized study at Department of Obstetrics and Gynecology, Benha University Hospital, since March 2013 till June 2015, after approval of the study protocol by the Local Ethical Committee. A written informed consent was obtained from eligible women before induction or at early stage of labour.

Women with singleton pregnancies of more than 28 weeks' gestation who are 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.

Our exclusion criteria are HELLP syndrome, eclampsia, abruptio placentae, malpresentation, polyhydramnios, previous uterine scar, chorioamnionitis and multiple pregnancies. All patients were in stable condition (no evidence of maternal hemodynamic instability or fetal distress) and their management afterwards followed the standards accepted in our country and established guidelines for the management of hypertensive disorders of pregnancy. For hypertensive crisis the first drug used was hydralazine (5 mg IV every 15 minutes to a
Sponsor: khalid abd aziz mohamed

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

prevention of postpartum haemorrhage


Original Primary Outcome: Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol [ Time Frame: 16 months ]

prevention of postpartum haemorrhage


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

Original Secondary Outcome:

  • Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol [ Time Frame: 16 months ]
    use of additional uterotonics,
  • Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol [ Time Frame: 16 months ]
    need for blood transfusion
  • Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol [ Time Frame: 16 months ]
    maternal adverse drug reaction,
  • Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol [ Time Frame: 16 months ]
    maternal complications and maternal death


Information By: Benha University

Dates:
Date Received: March 5, 2014
Date Started: March 2013
Date Completion:
Last Updated: February 13, 2017
Last Verified: February 2017