Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

This study has been completed.
Sponsor:
Information provided by:
Maternidade Escola Assis Chateaubriand
ClinicalTrials.gov Identifier:
NCT01231126
First received: October 29, 2010
Last updated: November 15, 2010
Last verified: January 2009
  Purpose

The purpose of this study is to evaluate the blood loss in induced vaginal delivery by misoprostol and caesarians section with induction attempt.


Condition Intervention Phase
Pregnancy
Induced Labor
Drug: Misoprostol
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Resource links provided by NLM:


Further study details as provided by Maternidade Escola Assis Chateaubriand:

Primary Outcome Measures:
  • Vaginal delivery [ Time Frame: 54 hours after the first pills ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • blood loss [ Time Frame: 24 hours after delivery ] [ Designated as safety issue: No ]
    To evaluate the blood loss in spontaneous vaginal deliveries and elective caesarians through the hemoglobin dosage pre and post delivery.


Enrollment: 161
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Citotec

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).

  Eligibility

Ages Eligible for Study:   14 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01231126

Locations
Brazil
Maternidade-Escola Assis Chateaubriand
Fortaleza, Ceará, Brazil, 60430-270
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: Paulo César Praciano de Sousa, Maternidade Escola Assis Chateaubriand
ClinicalTrials.gov Identifier: NCT01231126     History of Changes
Other Study ID Numbers: 051/09
Study First Received: October 29, 2010
Last Updated: November 15, 2010
Health Authority: Brazil: Ministry of Health

Keywords provided by Maternidade Escola Assis Chateaubriand:
Induced labor
Misoprostol
Postpartum blood
Erythrocyte indices
Vaginal delivery

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 August 27, 2014