Sublingual Misoprostol & Isoflurane During Caesarean Section - Full Text View

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:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Isoflurane Misoprostol

U.S. FDA Resources

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

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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

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:

Isoflurane
Misoprostol
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 22, 2013