Control of Blood Loss During Caesarean Section

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Cairo University
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
ClinicalTrials.gov Identifier:
NCT01412073
First received: August 5, 2011
Last updated: December 28, 2013
Last verified: December 2013
  Purpose

trial of 3 protocols to determine the best one to control blood loss during caesarean section


Condition Intervention Phase
Complications; Cesarean Section
Drug: oxytocin
Drug: Misoprostol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Randomized Trial to Determine the Best Strategy for the Control of Blood Loss at Elective Caesarean Section

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • amount of blood loss [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Haemoglobin % and haematocrit value [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: September 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oxytocin bolus

5 IU bolus iv over 3 minutes after delivery of the baby Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward.

Hemoglobin level and haematocrit value will be done as follow:-

  1. After admission of each case in the pre-operative period.
  2. Immediately post- operative.
  3. 24 hours post- operative.
Drug: oxytocin
group I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours
Other Name: syntocinon
Active Comparator: oxytocin bolus & oxytocin infusion
5 IU oxytoxin bolus over 3 minutes and 30 IU oxytocin infusion in 500 ml 0.9% saline over 4 hours after delivery of the baby
Drug: oxytocin
group I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours
Other Name: syntocinon
Active Comparator: misoprostol intrauterine
misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity
Drug: Misoprostol
misoprostol intrauterine 800 microgram placed intrauterine after delivery of the baby & the placenta
Other Name: cytotec

Detailed Description:

The study population will be divided into 3 groups each containing 200 women:

Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the baby.

Group (B): 200 patients will receive 5-IU oxytocin bolus over 3 minutes and 30-IU oxytocin infusion in 500 ml 0.9 % saline over 4 hours after delivery of the baby.

Group (C): 200 patients will receive misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity.

Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward.

Hemoglobin level and haematocrit value will be done as follow:-

  1. After admission of each case in the pre-operative period.
  2. Immediately post- operative.
  3. 24 hours post- operative.
  Eligibility

Ages Eligible for Study:   25 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients booked for elective cesarean section.
  • Singleton pregnancies.
  • Primigravida or multipara ,first cesarean section or previous .

Exclusion Criteria:

  • Patients with obstetric hemorrhage.
  • Uterine laceration.
  • Placenta previa.
  • Blood dyscrasias.
  • Large fibroids.
  • Multiple pregnancy.
  • Pre-eclampsia.
  • Marked maternal anemia.
  • Previous history of PPH.
  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: NCT01412073

Contacts
Contact: Waleed M El-khayat, M.D. 0105135542 ext +2 waleed_elkhyat@yahoo.com
Contact: Huda S Mahmoud, M.Sc. 0106820617 ext +2 dr_huda2009@yahoo.com

Locations
Egypt
faculty of medicine , Cairo University Recruiting
Cairo, Egypt, 12211
Contact: Waleed M El-khayat, M.D.    0105135542 ext +2    waleed_elkhyat@yahoo.com   
Contact: Huda S Mahmoud, M.Sc.    0106820617 ext +2    dr_huda2009@yahoo.com   
Principal Investigator: Waleed M El-Khayat, M.D.         
Sponsors and Collaborators
Cairo University
Investigators
Study Director: Waleed M El-khayat, M.D. Lecturer of Obstetrics & Gynecology , Faculty of medicine, Cairo University
  More Information

No publications provided

Responsible Party: Waleed El-khayat, Doctor, Cairo University
ClinicalTrials.gov Identifier: NCT01412073     History of Changes
Other Study ID Numbers: 582011
Study First Received: August 5, 2011
Last Updated: December 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cairo University:
caesarean section, intrapartum haemorrhage

Additional relevant MeSH terms:
Oxytocin
Misoprostol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 26, 2014