We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Control of Blood Loss During Caesarean Section

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412073
First Posted: August 8, 2011
Last Update Posted: October 7, 2014
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.
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Waleed El-khayat, Cairo University:

Primary Outcome Measures:
  • amount of blood loss [ Time Frame: 12 month ]

Secondary Outcome Measures:
  • Haemoglobin % and haematocrit value [ Time Frame: 12 month ]

Enrollment: 600
Study Start Date: September 2011
Study Completion Date: October 2014
Primary Completion Date: September 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

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.


Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT01412073


Locations
Egypt
faculty of medicine , Cairo University
Cairo, Egypt, 12211
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

Responsible Party: Waleed El-khayat, Doctor, Cairo University
ClinicalTrials.gov Identifier: NCT01412073     History of Changes
Other Study ID Numbers: 582011
First Submitted: August 5, 2011
First Posted: August 8, 2011
Last Update Posted: October 7, 2014
Last Verified: October 2014

Keywords provided by Waleed El-khayat, Cairo University:
caesarean section, intrapartum haemorrhage

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