NCT01466530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for phase_2 pregnancy

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_2 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

5.6 years

First QC Date

October 27, 2011

Last Update Submit

November 6, 2011

Conditions

PregnancyCesarean Delivery

Keywords

Full term pregnancy > 36 weeksCesarean deliveryGeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • estimated blood loss after caesarean delivery

    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 {\[maternal height (inches) x 50\] + \[maternal weight in pounds x 25\]})

    up to 24 hours

Secondary Outcomes (5)

  • uterine tone

    5 min, 10 min, 15 min, 20 min, 25 min, 30 min

  • need for additional oxytocin

    8 hrs

  • haematocrit levels

    24 hours, 48 hours

  • neonatal outcome

    1 min and 5 min

  • adverse effects

    48 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

sublingual two moistened white coated placebo tablets

Drug: Placebo

Misoprostol

ACTIVE COMPARATOR

sublingual misoprostol (400 µg)

Drug: Misoprostol

Interventions

PlaceboDRUG

received sublingual two moistened white coated placebo tablets which looked identical in size, colour, and packing to misoprostol tablet.

Also known as: Group A
Placebo
MisoprostolDRUG

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).

Also known as: Group M
Misoprostol

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine, Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Mohamed R El Tahan, MD

    College of medicine, Manoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 27, 2011

First Posted

November 8, 2011

Study Start

January 1, 2006

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

EG(1)