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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.
 
ClinicalTrials.gov Identifier: NCT02086994
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
khalid abd aziz mohamed, Benha University

Tracking Information
First Submitted Date  ICMJE March 5, 2014
First Posted Date  ICMJE March 14, 2014
Last Update Posted Date February 15, 2017
Study Start Date  ICMJE March 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2014)
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 Measures  ICMJE
 (submitted: March 9, 2014)
Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol [ Time Frame: 16 months ]
prevention of postpartum haemorrhage
Change History Complete list of historical versions of study NCT02086994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
measurement of blood loss during second stage of labour [ Time Frame: 24 hours after delivery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2014)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Postpartum Hemorrhage in Patients With Severe Preeclampsia Using Carbetocin Versus Misoprostol
Official Title  ICMJE 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 Description

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 maximum total dose of 20 mg) and, if this was ineffective, Nifedipine (Epilat): 10 to 20 mg orally / 30 min (max 50 mg), Then 10-20 mg /4-6 h (max 120 mg/day) or labetalol (20 mg IV every 10 minutes to a maximum total dose of 300 mg). No patient needed additional treatment for their symptoms or developed antepartum complications that required admission to the intensive care unit. All patients were evaluated hourly and received magnesium sulphate to prevent eclampsia during the pregnancy and for a minimum of 24 hours postpartum.

The patients (60) were divided into two groups, Group A (30) received a single dose of carbetocin (100 μg in 1 mL ampoule, Pabal) while Group B (30) received misoprostol (600 μg, 3 tables) sublingually after the delivery of the anterior shoulder of the baby.

The third stage of labour is managed as usual by clamping and cutting of umbilical cord, waiting for signs of placental separation and delivering the placenta by controlled cord traction.

Duration of the 3rd stage of labour is calculated. Patient is kept in labor room under observation for a period of 1 h and any complaint such as nausea, vomiting, fever, headache, chills, diarrhoea and shivering is noted. In cases of uterine atony (determined by physical examination and continuous postpartum bleeding) uterus is massaged and additional uterotonics were given and noted (oxytocin and/or prostaglandin, at the discretion of the attending physician). Any requirement for manual removal of the placenta or blood transfusion is also recorded.

The following laboratory assessments (hemoglobin, hematocrit, platelets, and renal and liver function tests) are performed in every patient on admission and postpartum. Vital signs (blood pressure, heart rate, respiratory rate) and urine output are measured every hour until at least 24 hours after delivery.

Measurement of blood loss A clean plastic lined absorbent drape is placed under the woman's buttocks to collect all the blood lost after delivery of the baby and drainage of the amniotic fluid. The drape is changed as many times as needed. The woman stays on the drape or asked to wear a pad over the next 60 minutes. In the case of severe haemorrhage, we follow the usual guidelines for management of postpartum haemorrhage, and the supplemental treatment is registered. All drapes and pads are weighed on an electronic scale and the known dry weight of the linen is subtracted. As 1 ml of blood weighs close to 1 g, the balance in grams is assumed to be the total blood loss in ml.

Haemoglobin concentration is measured before, 2 hours and 24 hours after delivery.

The rate of haemorrhage at labour third phase is determined by observation estimation considering the amount of blood under the patient. The rate of haemoglobin and haematocrit are measured at hospitalization and also 2 h, 24 h after delivery and then are recorded. At this interval, the patients are evaluated in terms of possible complications of administered drugs such as vomiting, diarrhoea, shivering, pyrexia, and headache).

All patients have the Foley catheter in situ for 24 hours after delivery and the amount of urine was monitored hourly.

This study has no external funding source. No author had any potential relationships that may pose conflict of interest.

Outcome measures Our primary outcome measure is postpartum haemorrhage, defined as a blood loss of ≥ 500 ml. We analyse the blood loss, change in haemoglobin concentration between admission and discharge. While secondary outcomes include use of additional uterotonics, need for blood transfusion, maternal adverse drug reaction (such as headache, vomiting, abdominal pain, pruritus, tacky or bradycardia), sever maternal complications (such as seizures or need for ICU admission) and maternal death.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Severe Pre-eclampsia, Postpartum Condition or Complication
Intervention  ICMJE
  • Drug: misoprostol
    given after the delivery of the anterior shoulder of the baby.
    Other Names:
    • misoprost
    • cytotec
    • misotec
  • Drug: carbetocin
    given after delivery of anterior shoulder
    Other Name: pabal
Study Arms  ICMJE
  • Active Comparator: cabetocin
    a single dose of carbetocin (100 μg in 1 mL ampoule, Pabal) given intravenously after delivery of anterior shoulder
    Intervention: Drug: carbetocin
  • Active Comparator: misoprostol
    misoprostol (600 μg, 3 tables) sublingually after the delivery of the anterior shoulder of the baby.
    Intervention: Drug: misoprostol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 42 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02086994
Other Study ID Numbers  ICMJE khalid77
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party khalid abd aziz mohamed, Benha University
Study Sponsor  ICMJE khalid abd aziz mohamed
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Benha University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP