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

Effects of topical magnesium sulfate on duration of labor and childbirth experience: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100414003706N40
Enrollment
98
Registered
2021-11-21
Start date
2021-12-10
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

Prolonged labor. Prolonged first stage (of labor)

Interventions

Intervention 1: Intervention group: Just after onset of active phase of labor (cervical dilation of 4-5 cm with regular uterine contractions), 10 mL of magnesium sulfate 50% made by Yara Teb Samen Ph

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSahar Ruhzendeh

Tabriz University of Medical Sciences

Saharruhzendeh10@gmail.com+98 41 3479 6770

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026