Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Phase 4

Completed

• Conditions: Pregnancy; Induced Labor
• Interventions: Drug: Misoprostol

• Registration Number: NCT01231126
• Lead Sponsor: Maternidade Escola Assis Chateaubriand

Brief Summary

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

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 Timeline

• Study Start: 2008-02
• Status Verified: 2009-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2010-10-29
• Study First Submitted QC: 2010-10-29
• Study First Posted: 2010-11-01
• Last Update Submitted: 2010-11-15
• Last Update Posted: 2010-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 161

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
spontaneous vaginal deliveries	Misoprostol	-
elective caesarians	Misoprostol	-
induced vaginal delivery by misoprostol	Misoprostol	-
caesarians section with induction attempt	Misoprostol	-

Primary Outcome Measures

Name	Time	Method
Vaginal delivery	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

Name	Time	Method
blood loss	24 hours after delivery	To evaluate the blood loss in spontaneous vaginal deliveries and elective caesarians through the hemoglobin dosage pre and post delivery.

Trial Locations

Locations (1)

Maternidade-Escola Assis Chateaubriand; 🇧🇷 Fortaleza, Ceará, Brazil