Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Maternidade Escola Assis Chateaubriand

Status and phase: Completed; Phase 4

Conditions: Induced Labor; Pregnancy

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01231126

051/09

Details and patient eligibility

About

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

Full 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).

Enrollment: 161 patients

Sex: Female

Ages: 14 to 40 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

161 participants in 4 patient groups, including a placebo group

spontaneous vaginal deliveries

Placebo Comparator group

Treatment:

Drug: Misoprostol

elective caesarians

Placebo Comparator group

Treatment:

Drug: Misoprostol

induced vaginal delivery by misoprostol

Experimental group

Treatment:

Drug: Misoprostol

caesarians section with induction attempt

Experimental group

Treatment:

Drug: Misoprostol