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Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

NCT ID: NCT01231126

Last Updated: 2010-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-01-31

Brief Summary

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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

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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).

Conditions

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Pregnancy Induced Labor

Keywords

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Induced labor Misoprostol Postpartum blood Erythrocyte indices Vaginal delivery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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spontaneous vaginal deliveries

Group Type PLACEBO_COMPARATOR

Misoprostol

Intervention Type DRUG

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.

elective caesarians

Group Type PLACEBO_COMPARATOR

Misoprostol

Intervention Type DRUG

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.

induced vaginal delivery by misoprostol

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

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.

caesarians section with induction attempt

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Citotec

Eligibility Criteria

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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;
Minimum Eligible Age

14 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maternidade Escola Assis Chateaubriand

OTHER

Sponsor Role lead

Responsible Party

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Maternidade Escola Assis Chateaubriand

Principal Investigators

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Paulo César Praciano de Sousa, Mestre

Role: PRINCIPAL_INVESTIGATOR

Maternidade Escola Assis Chateaubriand

Francisco Edson de Lucena Feitosa, Doutor

Role: STUDY_DIRECTOR

Maternidade Escola Assis Chateaubriand

Locations

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Maternidade-Escola Assis Chateaubriand

Fortaleza, Ceará, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 19187376 (View on PubMed)

Related Links

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http://www.meac.ufc.br

site of Maternidade-Escola Assis Chateaubriand

Other Identifiers

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051/09

Identifier Type: -

Identifier Source: org_study_id