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Combined Effects of Dexamethasone and Hyoscine on Labor

Comparison of the Combined Effects of Dexamethasone and Hyoscine versus Single Drug Administration on Labor Progression and Maternal and Neonatal Outcomes: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250307064958N1
Enrollment
128
Registered
2025-04-28
Start date
2025-05-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Labor, normal delivery. Encounter for full-term uncomplicated delivery

Interventions

Intervention 1: Intervention Group 1: Combined medication group will receive dexamethasone 8 mg intramuscular injection 12 hours before the onset of induction of labor and hyoscine 20 mg intravenous i

Sponsors

Ardabil University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Singleton pregnancy Term pregnancy (37-42 weeks) Cephalic presentation Spontaneous onset of labor Maternal age between 18-45 years

Exclusion criteria

Exclusion criteria: Underlying maternal disease Known fetal abnormalities Placental abnormalities Preterm labor Multiple gestations Contraindications to dexamethasone or hyoscine History of cesarean section or uterine surgery Fetal distress at admission

Design outcomes

Primary

MeasureTime frame
Duration of first stage of labor. Timepoint: From the beginning of the first stage of labor (4 cm cervical dilation) until its completion (full cervical dilation). Method of measurement: Time recording by midwife or obstetrician using the digital clock in the labor ward.;Duration of second stage of labor. Timepoint: From the beginning of the second stage of labor (full cervical dilation) until the delivery of the baby. Method of measurement: Time recording by midwife or obstetrician using the digital clock in the labor ward.;Neonatal Apgar score at 1 minute. Timepoint: First minute after birth. Method of measurement: Standard Apgar scoring system by pediatrician or midwife.;Neonatal Apgar score at 5 minutes. Timepoint: Fifth minute after birth. Method of measurement: Standard Apgar scoring system by pediatrician or midwife.;Postpartum hemorrhage volume. Timepoint: From placental delivery until 2 hours after childbirth. Method of measurement: Measurement of blood volume using calibrated drape and weighing blood-soaked gauzes.;Postpartum pain score. Timepoint: 2, 6, and 12 hours after childbirth. Method of measurement: Visual Analogue Scale (VAS) with score of 0 to 10.;Maternal satisfaction score. Timepoint: 24 hours after childbirth. Method of measurement: Standard childbirth satisfaction questionnaire with 5-point Likert scale.

Secondary

MeasureTime frame
????? ??? ??????. Timepoint: During labor, from active phase until placental delivery. Method of measurement: Standard checklist of obstetric complications completed by obstetrician.;Neonatal birth weight. Timepoint: Immediately after birth. Method of measurement: Calibrated digital baby scale with 10-gram precision.;Neonatal birth length. Timepoint: Immediately after birth. Method of measurement: Infant stadiometer with 0.5 cm precision.;Need for maternal postpartum interventions. Timepoint: Up to 24 hours after childbirth. Method of measurement: Standard checklist of postpartum interventions completed by obstetrician.;Maternal postpartum complications. Timepoint: Up to 48 hours after childbirth. Method of measurement: Standard checklist of maternal postpartum complications completed by obstetrician.;Neonatal postpartum complications. Timepoint: Up to 48 hours after birth. Method of measurement: Standard checklist of neonatal complications completed by pediatrician.;Need for neonatal intensive care unit admission. Timepoint: Up to 48 hours after birth. Method of measurement: Documentation of NICU admission by pediatrician.;Frequency of uterine contractions. Timepoint: During labor, from active phase until full cervical dilation. Method of measurement: Counting number of contractions in 10 minutes by midwife.;Intensity of uterine contractions. Timepoint: During labor, from active phase until full cervical dilation. Method of measurement: External tocodynamometer and midwife report.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTorkan Barzegari Sedghiani

Ardabil University of Medical Sciences

torkanbarzegari94@gmail.com+98 45 3324 8888

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026