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Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01231126
First Posted: November 1, 2010
Last Update Posted: November 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maternidade Escola Assis Chateaubriand
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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

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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

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): 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
First Submitted: October 29, 2010
First Posted: November 1, 2010
Last Update Posted: November 16, 2010
Last Verified: January 2009

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
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics