Isoxsuprine in prevention of preterm labor

Effect of maintenance therapy with Isoxsuprine in prevention of preterm labor

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201101115591N1

Enrollment

Registered

2011-06-08

Start date

2009-09-23

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 labour. Preterm labour

Interventions

Intervention 1: In case group: Isoxsuprine 10 mg tablet TDS since 26 wk continue throughout pregnancy. Intervention 2: In control group: Placebo tablet TDS since 26 wk continue throughout pregnancy.

Treatment - Drugs

Placebo

In case group: Isoxsuprine 10 mg tablet TDS since 26 wk continue throughout pregnancy.

In control group: Placebo tablet TDS since 26 wk continue throughout pregnancy.

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1-pregnant women, 2-singleton pregnancy, 3-gestational age 26-34 weeks, 4-preterm labor pain, 5-intact amniotic membrane. Exclusion criteria: 1-gestational age >34 wk, 2-premature rupture of membrane, 3-chorioamnionitis, 4-antepartum hemorrhage (abraption, placental, previa), 5-multiple pregnancy, 6-systemic diseases (preclampsia, diabetes melitus, cardiovascular disorders, renal diseases, asthma, hyperthyroidy,...), 7-congenital abnormality, 8-urinary tract infection, 9-past history of preterm labor.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Contractions stop for 48 hours. Timepoint: From stop of premature contractions. Method of measurement: hour.;Stop of contraction for one week. Timepoint: Since stop of contraction. Method of measurement: week.;Stop of contraction till 34 wks of gestation. Timepoint: Since stop of contraction. Method of measurement: week.;Term delivery. Timepoint: 37 wk of gestation till delivery. Method of measurement: week.	—

Measure

Time frame

Contractions stop for 48 hours. Timepoint: From stop of premature contractions. Method of measurement: hour.;Stop of contraction for one week. Timepoint: Since stop of contraction. Method of measurement: week.;Stop of contraction till 34 wks of gestation. Timepoint: Since stop of contraction. Method of measurement: week.;Term delivery. Timepoint: 37 wk of gestation till delivery. Method of measurement: week.

—

Secondary

Measure	Time frame
Side effects. Timepoint: during pregnancy. Method of measurement: pulse rate, respiratory rate, blood pressure.;NICU admission. Timepoint: from time of birth. Method of measurement: day.;Apgar 1st and 5th minutes. Timepoint: from time of birth. Method of measurement: Score 10/10.;Birth weight. Timepoint: time of birth. Method of measurement: kg.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlavi Azin

Hormozgan University of Medical Sciences

alavi-a@razi.tums.ac.ir+98 76 1333 3625

Outcome results

None listed

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