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Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01231126
Enrollment
161
Registered
2010-11-01
Start date
2008-02-29
Completion date
2009-01-31
Last updated
2010-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induced Labor, Pregnancy

Keywords

Induced labor, Misoprostol, Postpartum blood, Erythrocyte indices, Vaginal delivery

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).

Interventions

DRUGMisoprostol

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.

Sponsors

Maternidade Escola Assis Chateaubriand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 40 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Vaginal delivery54 hours after the first pillsProcedures 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

MeasureTime frameDescription
blood loss24 hours after deliveryTo evaluate the blood loss in spontaneous vaginal deliveries and elective caesarians through the hemoglobin dosage pre and post delivery.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026