Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

November 15, 2010 updated by: Maternidade Escola Assis Chateaubriand
The purpose of this study is to evaluate the blood loss in induced vaginal delivery by misoprostol and caesarians section with induction attempt.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods: it was a study achieved with 101 pregnant women with indication to induced delivery labor that were evaluated by the hemoglobin dosage pre and post delivery for estimate the blood loss at delivery. Patients were submitted to transabdominal obstetric ultrasound and basal cardiotocography. Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six. The control group was formed by 30 patients that began an spontaneously labor and 30 patients that achieved caesarians electively. The study of hemoglobin before and after delivery was evaluated through ANOVA to repeated measures, where it was verified the time effect (pre and post delivery) and the effect of the group (with and without use of misoprostol).

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-270
        • Maternidade-Escola Assis Chateaubriand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Indication of early elective delivery by induction of labor (pre-eclampsia, HELLP syndrome, chronic hypertension, prolonged gestation, diabetes mellitus, gestational diabetes, heart disease, thyroid disease;
  • pregnancy with living fetus;
  • vertex cephalic presentation;
  • estimated fetal weight by ultrasound > 2500g and <4000g;
  • Amniotic fluid index (AFI)> 5 cm, except in cases of premature rupture of membranes in which AFI <5 cm would be allowed;
  • cardiotocography (CTG) antepartum normal;
  • Bishop Score less than or equal to 6;
  • Determination of hemoglobin pre and post-partum.

Exclusion Criteria:

  • Prior Cesarean section;
  • previous uterine scar by myomectomy;
  • Fetal presentation anomalous;
  • Evidence of fetal abnormal (CTG, Ultrasound or Doppler);
  • Fetal growth restriction;
  • Gestation multiple;
  • genital bleeding;
  • tumors, malformations and / or ulceration in the region vulvoperineal and birth canal;
  • No determination of hemoglobin pre-and post-partum;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: spontaneous vaginal deliveries
Drug: Misoprostol
Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six.
Other Names:
  • Citotec
Placebo Comparator: elective caesarians
Drug: Misoprostol
Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six.
Other Names:
  • Citotec
Experimental: induced vaginal delivery by misoprostol
Drug: Misoprostol
Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six.
Other Names:
  • Citotec
Experimental: caesarians section with induction attempt
Drug: Misoprostol
Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six.
Other Names:
  • Citotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal delivery
Time Frame: 54 hours after the first pills
Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six.
54 hours after the first pills

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss
Time Frame: 24 hours after delivery
To evaluate the blood loss in spontaneous vaginal deliveries and elective caesarians through the hemoglobin dosage pre and post delivery.
24 hours after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maternidade Escola Assis Chateaubriand

Investigators

  • Principal Investigator: Paulo César Praciano de Sousa, Mestre, Maternidade Escola Assis Chateaubriand
  • Study Director: Francisco Edson de Lucena Feitosa, Doutor, Maternidade Escola Assis Chateaubriand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 29, 2010

First Submitted That Met QC Criteria

October 29, 2010

First Posted (Estimate)

November 1, 2010

Study Record Updates

Last Update Posted (Estimate)

November 16, 2010

Last Update Submitted That Met QC Criteria

November 15, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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