Is intramuscular progesterone as effective as oral nifedipine for treating threatened preterm labor?

Clinical trial comparing the effect of 300 milligram intramuscular progesterone with oral nifedipine on threatened preterm labor in pregnant women hospitalized with threatened preterm labor

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201112198469N1

Enrollment

Registered

2015-12-08

Start date

2011-12-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Preterm Labor. Preterm labour without delivery

Interventions

Intervention 1: Intervention 1: Intra-mascular progestrone 200 mg (100 mg in each gluteus maximus). Intervention 2: Intervention 2: Oral nifedipine with standard dosage (started with a loading dose of

Treatment - Drugs

Intervention 1: Intra-mascular progestrone 200 mg (100 mg in each gluteus maximus)

Intervention 2: Oral nifedipine with standard dosage (started with a loading dose of 30 mg and continued with 10-20 mg every 4-6 hours until pain relief)

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Women aged 18-45 years; women with single pregnancy; women with pregnancy between 26-34 weeks of gestational age; women who referred with active uterine contractions and admitted for threatened preterm labor. Exclusion criteria: women with active labor phase (Cervical dilatation>3cm; vaginal bleeding; rapture of membrane; over distension of the uterus (multifetal gestation or polihydramnios); any systemic infection; oral temperature>38; intrauterine growth retard (IUGR) fetus; fetal distress; blood pressure>140/90 mmHg; any contraindication for progestrone or nifedipine administration; history of any thromboembolic disorders.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Stopping uterine contractions. Timepoint: Before intervention, each hour until contractions stop, 12 hours after stopping contractions. Method of measurement: Tocometry.	—

Secondary

Measure	Time frame
Delivery time. Timepoint: Date of neonate's birth. Method of measurement: Gestational age at the time of delivery.;Reccurance of preterm contractions. Timepoint: every week. Method of measurement: tocometry.;Neonate status. Timepoint: Time of delivery, time of discharge. Method of measurement: Apgar score, hospitalization period, need for NICU.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Najmi

Tehran University of Medical Sciences, Tehran, Iran

zahranaj@student.tums.ac.ir+98 21 6655 5447

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 25, 2026