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Treatment of preterm labor

A comparative study on the efficacy of nifedipine and indomethacin for prevention of preterm birth as monotherapy and combination therapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20091023002624N26
Enrollment
150
Registered
2018-08-03
Start date
2016-05-01
Completion date
Unknown
Last updated
2018-09-11

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

Conditions

Condition 1: preterm birth, Preterm delivery, preterm uterine contractions, preterm labor. Condition 2: preterm birth, Preterm delivery, preterm uterine contractions, preterm labor. Condition 3: preterm birth, Preterm delivery, preterm uterine contractions, preterm labor. Preterm labour and delivery Preterm spontaneous labour with preterm delivery Preterm labor without delivery

Interventions

Intervention 1: Intervention group: group A
100 mg rectal indomethacin was administered along with an oral placebo. If the patient responded to the initial treatment after two hours, 25 mg of oral indomethacin was administered every 4 hours plu
20 mg oral nifedipine was administered along with a rectal placebo. After 90 minutes, more 20 mg of oral nifedipine was administered. In case of responding to the initial treatment, 20 mg of oral nife
a combination of rectal indomethacin and oral nifedipine was administered per protocol as mentioned above.

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: gestational age of 26 to 34 weeks singleton uterine contractions with a frequency of at least 4 forceful uterine contractions per 20 minutes or a cervical dilatation of minimum 1 cm and minimum 50% cervical effacement.

Exclusion criteria

Exclusion criteria: rupture of membrane intrauterine fetal death cervical dilatation of more than 5 cm multiple pregnancy receiving tocolytic within past 24 hours polyhydramnios preeclampsia and eclampsia vaginal bleeding more than bloody show any maternal and fetal condition that contradict with receiving tocolitics severe fetal anomalies contradict fetal life fetal distress

Design outcomes

Primary

MeasureTime frame
Inhibiting uterine contractions for 48 hours. Timepoint: 48 hours after intervention. Method of measurement: contraction monitoring by tocometer.;Delivery before 37 weeks of gestation. Timepoint: Birth date. Method of measurement: Data sheets.

Secondary

MeasureTime frame
Inhibiting the contractions in the first 2 hours after intervention. Timepoint: 2 hours after intervention. Method of measurement: Tocometer.;Delivery within 7 days after intervention. Timepoint: 7 days after intervention. Method of measurement: Birth date.;Gestational age at the time of birth. Timepoint: time of birth. Method of measurement: birth date.;Duration of prolongation of pregnancy. Timepoint: birth date. Method of measurement: Data sheets.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Kashanian

Iran University of Medical Sciences

maryamkashanian@yahoo.com+98 21 5563 3244

Outcome results

None listed

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