Trial | NCT01231126  Report issue

Official Title

Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    161
The purpose of this study is to evaluate the blood loss in induced vaginal delivery by misoprostol and caesarians section with induction attempt.
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 Started
Feb 29
2008
Primary Completion
Jan 31
2009
Study Completion
Jan 31
2009
Last Update
Nov 16
2010
Estimate

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

spontaneous vaginal deliveries Placebo Comparator

elective caesarians Placebo Comparator

induced vaginal delivery by misoprostol Experimental

caesarians section with induction attempt Experimental

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;
No Results Posted