Sublingual Misoprostol & Isoflurane During Caesarean Section

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University
ClinicalTrials.gov Identifier:
NCT01466530
First received: October 27, 2011
Last updated: November 6, 2011
Last verified: November 2011
  Purpose

Misoprostol would reduce the uterine bleeding after caesarean delivery, without harmful effects on either mother or baby. The investigators postulated that the use of sublingual misoprostol during isoflurane anaesthesia for uncomplicated caesarean delivery would reduce maternal haemorrhage, uterine atonic effects, and the need for additional uterotonic agents, without harmful effects on either mother or baby. Therefore, the present study was designed to evaluate the effects of preoperative sublingual misoprostol on maternal blood loss, uterine tone, the need for additional oxytocin and neonatal outcome after elective caesarean delivery under isoflurane anaesthesia.


Condition Intervention Phase
Pregnancy
Cesarean Delivery
Drug: Placebo
Drug: Misoprostol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Preoperative Sublingual Misoprostol on Uterine Tone During Isoflurane Anaesthesia for Caesarean Section

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • estimated blood loss after caesarean delivery [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]
    estimated blood loss (EBL) = pregnancy blood volume (ml) (EBV) x [preoperative haematocrit - postoperative haematocrit] / preoperative haematocrit, where EBV measured as shown in the following formula; (0.75 x {[maternal height (inches) x 50] + [maternal weight in pounds x 25]})


Secondary Outcome Measures:
  • uterine tone [ Time Frame: 5 min, 10 min, 15 min, 20 min, 25 min, 30 min ] [ Designated as safety issue: No ]
    The obstetrician who was blinded to the study group, assessed the uterine tone by palpation every three minutes after delivery of the placenta and rated the degree of uterine contraction on a 10-cm VAS (0: well contracted; 10: completely relaxed).

  • need for additional oxytocin [ Time Frame: 8 hrs ] [ Designated as safety issue: No ]
    If uterine tone remained unsatisfactory for 3 min after delivery, an additional 5-unit bolus of oxytocin was administered. The number of patients received oxytocin was recorded

  • haematocrit levels [ Time Frame: 24 hours, 48 hours ] [ Designated as safety issue: No ]
    haematocrit levels was recorded before and 48 hours after cesarean delivery

  • neonatal outcome [ Time Frame: 1 min and 5 min ] [ Designated as safety issue: Yes ]
    Apgar score and clinical signs after delivery

  • adverse effects [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    the presence of postoperative side effects such as nausea and vomiting, diarrhoea, abdominal pain, pyrexia, and shivering were recorded.


Enrollment: 366
Study Start Date: January 2006
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
sublingual two moistened white coated placebo tablets
Drug: Placebo
received sublingual two moistened white coated placebo tablets which looked identical in size, colour, and packing to misoprostol tablet.
Other Name: Group A
Active Comparator: Misoprostol
sublingual misoprostol (400 µg)
Drug: Misoprostol
sublingual misoprostol was given by putting two moistened tablets of misoprostol (400 µg) under the tongue and allowing them to dissolve (Misotac®, Sigma Pharmaceutical Industries, Egypt) (200 µg/tablet).
Other Name: Group M

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists class I and II
  • parturients aged 18-35 years
  • uncomplicated singleton pregnancies
  • Gestational age >= 36 weeks
  • elective caesarean delivery
  • refused regional anaesthesia
  • requested general anaesthesia.

Exclusion Criteria:

  • allergy to prostaglandins
  • bronchial asthma
  • anaemia
  • bleeding disorders
  • cardiac diseases
  • inflammatory bowel diseases
  • multiple pregnancies
  • preeclampsia
  • placenta praevia
  • abruptio placenta
  • previous postpartum haemorrhage
  • antepartum haemorrhage
  • grand multiparity
  • uterine fibroids
  • intrauterine growth restriction
  • fetal abnormality
  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: NCT01466530

Locations
Egypt
College of Medicine, Mansoura University
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Mohamed R El Tahan, MD College of medicine, Manoura University
  More Information

No publications provided

Responsible Party: Mohamed R El Tahan, Associate Professor, Mansoura University
ClinicalTrials.gov Identifier: NCT01466530     History of Changes
Other Study ID Numbers: 2011-2
Study First Received: October 27, 2011
Last Updated: November 6, 2011
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
Full term pregnancy > 36 weeks
Cesarean delivery
General anesthesia

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

ClinicalTrials.gov processed this record on October 01, 2014