Clinical trial NCT01231126: Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour
Official title: Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Induced Labor
Keywords: Induced labor
Misoprostol
Postpartum blood
Erythrocyte indices
Vaginal delivery
Lead sponsor: Maternidade Escola Assis Chateaubriand
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 161
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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;

Primary outcomes:
measure: Vaginal delivery
timeFrame: 54 hours after the first pills
Secondary outcomes:
measure: blood loss
timeFrame: 24 hours after delivery
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Maternidade-Escola Assis Chateaubriand
state: Ceará
Study officials:
affiliation: Maternidade Escola Assis Chateaubriand
name: Paulo César Praciano de Sousa, Mestre
role: PRINCIPAL_INVESTIGATOR
affiliation: Maternidade Escola Assis Chateaubriand
name: Francisco Edson de Lucena Feitosa, Doutor
role: STUDY_DIRECTOR
References:
citation: ElSedeek MSh, Awad EE, ElSebaey SM. Evaluation of postpartum blood loss after misoprostol-induced labour. BJOG. 2009 Feb;116(3):431-5. doi: 10.1111/j.1471-0528.2008.02054.x.