Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Study Overview
=================
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).

Official Title
-----------------
Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Conditions
-----------------
Pregnancy, Induced Labor

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
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;

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: spontaneous vaginal deliveries<br> | Drug: Misoprostol<br>* 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.<br>* Other names: Citotec;|
| Placebo Comparator: elective caesarians<br> | Drug: Misoprostol<br>* 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.<br>* Other names: Citotec;|
| Experimental: induced vaginal delivery by misoprostol<br> | Drug: Misoprostol<br>* 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.<br>* Other names: Citotec;|
| Experimental: caesarians section with induction attempt<br> | Drug: Misoprostol<br>* 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.<br>* Other names: Citotec;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal delivery | 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. | 54 hours after the first pills | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | To evaluate the blood loss in spontaneous vaginal deliveries and elective caesarians through the hemoglobin dosage pre and post delivery. | 24 hours after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Induced labor, Misoprostol, Postpartum blood, Erythrocyte indices, Vaginal delivery