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Completed

NCT Number: NCT01231126

Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

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

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Key information

Age range

14 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Maternidade-Escola Assis Chateaubriand

Fortaleza, Ceará, 60430-270, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Misoprostol

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Maternidade Escola Assis Chateaubriand

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 1, 2010
Registry last updated
Nov 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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