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Sublingual Misoprostol & Isoflurane During Caesarean Section

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ClinicalTrials.gov Identifier: NCT01466530
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pregnancy Cesarean Delivery Drug: Placebo Drug: Misoprostol Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Preoperative Sublingual Misoprostol on Uterine Tone During Isoflurane Anaesthesia for Caesarean Section
Study Start Date : January 2006
Primary Completion Date : August 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. estimated blood loss after caesarean delivery [ Time Frame: up to 24 hours ]
    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 :
  1. uterine tone [ Time Frame: 5 min, 10 min, 15 min, 20 min, 25 min, 30 min ]
    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).

  2. need for additional oxytocin [ Time Frame: 8 hrs ]
    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

  3. haematocrit levels [ Time Frame: 24 hours, 48 hours ]
    haematocrit levels was recorded before and 48 hours after cesarean delivery

  4. neonatal outcome [ Time Frame: 1 min and 5 min ]
    Apgar score and clinical signs after delivery

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


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

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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): 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

Responsible Party: Mohamed R El Tahan, Associate Professor, Mansoura University
ClinicalTrials.gov Identifier: NCT01466530     History of Changes
Other Study ID Numbers: 2011-2
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Mohamed R El Tahan, Mansoura University:
Full term pregnancy > 36 weeks
Cesarean delivery
General anesthesia

Additional relevant MeSH terms:
Misoprostol
Isoflurane
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants