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Comparison of effect of topical magnesium sulfate and placebo (distilled water) on duration of labor and childbirth experience

Phase 3
Conditions
Prolonged labor.
Prolonged first stage (of labor)
O63.0
Registration Number
IRCT20100414003706N40
Lead Sponsor
Tabriz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Female
Target Recruitment
98
Inclusion Criteria

Women aged 18-35 years, nulliparoue or with 1-2 parous without a history of cesarean section
Body mass index 19.8-30 kg/m2 (based on weight of pre-pregnancy or first trimester of pregnancy)
A live singleton term fetus (gestational age of 37-41 weeks) in estimated weight 2500 to 4000 g and cephalic presentation
Having sufficient literacy to read and understand study questionnaires
Spontaneous or non-spontaneous onset of labor process
Cervical effacement 40-70%
Station -2 to 0

Exclusion Criteria

History of infertility
Contraindications to vaginal delivery including placental abruption, umbilical cord prolapse, cephalopelvic disproportion (CPD)
Fetal heart rate disorders in the pre-intervention stage
High risk pregnancy (bleeding in the third trimester, placental abruption, placenta previa, fetal growth disorder, etc.)
Risky diseases (such as severe anemia (hemoglobin less than 7 g/dL) or blood disorders, heart disease, lung disease, connective tissue and smooth muscle problems)
Unwillingness to participate in the study

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The interval between intervention initiation and childbirth. Timepoint: After delivery. Method of measurement: Timer.;Score of maternal birth experience. Timepoint: One month after delivery. Method of measurement: Childbirth Experience Questionnaire 2.0.
Secondary Outcome Measures
NameTimeMethod
Score of birth satisfaction. Timepoint: 12-24 h after childbirth. Method of measurement: Birth satisfaction scale-revised questionnaire.;Pain intensity. Timepoint: A?bout 30 min before the intervention and then 1, 2 and 3 h after starting the intervention. Method of measurement: Visual Analog Scale.;Duration of the second stage of labor. Timepoint: After fetal expulsion. Method of measurement: Timer.;Duration of the third stage of labor. Timepoint: After complete expulsion of the placenta. Method of measurement: Timer.;Bishop Score. Timepoint: Just before the intervention and 2 h after starting the intervention. Method of measurement: Bishop Scoring Table.;Hemoglobin and hematocrit. Timepoint: 12- 24 h after delivery. Method of measurement: Laboratory test.;Childbirth fear. Timepoint: At baseline and two h after starting intervention. Method of measurement: Delivery Fear Scale.;Severity of postpartum fear. Timepoint: 12-24 h and one Month after delivery. Method of measurement: Wijma Version B scale.
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