To evaluate efficacy and safety of Isoxsuprine Hydrochloride in females with preterm labor.

A Prospective, Single Center, Open-Label, Non-Comparative Study For Evaluation Of Efficacy And Safety Study Of Isoxsuprine Hydrochloride As Uterine Relaxant In Preterm Labor

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/04/013262

Enrollment

Registered

2018-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Preterm labor

Interventions

Intervention1: A.Isoxsuprine hydrochloride injection I.P.-Each ml contains Isoxsuprine Hydrochloride IP 5 mg B.Isoxsuprine hydrochloride 40mg sustained release capsule. : All study participants wil

Eligibility

Inclusion criteria

Inclusion criteria: 1.Gestational age 24-37 weeks 2.Regular uterine contractions, 2 or more than 2 per 20 minutes each lasting for at least 20 seconds 3.Cervical dilatation less than 3 cm 4.Cervical effacement less than 50%. 5.Intact membrane

Exclusion criteria

Exclusion criteria: 1.Antepartum hemorrhage 2.Fetal malformations 3.Pregnancy with heart disease and diabetes mellitus 4.Multiple pregnancies 5.Hydramnios 6.Prolonged PROM

Design outcomes

Primary

Measure	Time frame
1.Percentage of patients with Isoxsuprine hydrochloride injection having successful tocolysis in first 24 hours. 2.Percentage of patients with Isoxsuprine hydrochloride Retard 40mg capsule having successful tocolysis in next 24 hours. Timepoint: Baseline (0 Hour) 24-Hours 48-Hours Time of delivery	—

Secondary

Measure	Time frame
1.Percentage of patients with adverse effects during first 24 hours of Isoxsuprine hydrochloride injection therapy. 2.Percentage of patients with adverse effects during maintenance therapy with Isoxsuprine hydrochloride Retard 40mg capsule. 3.Maternal Latency period after usage of Isoxsuprine hydrochloride as tocolytic agent in the management of preterm labor. 4.Fetal Apgar Score (1 min and 5 min) after usage of Isoxsuprine hydrochloride as tocolytic agent in the management of preterm labor.Timepoint: Baseline (0 Hour) 24-Hours 48-Hours Time of delivery	—

Measure

Time frame

1.Percentage of patients with adverse effects during first 24 hours of Isoxsuprine hydrochloride injection therapy. 2.Percentage of patients with adverse effects during maintenance therapy with Isoxsuprine hydrochloride Retard 40mg capsule. 3.Maternal Latency period after usage of Isoxsuprine hydrochloride as tocolytic agent in the management of preterm labor. 4.Fetal Apgar Score (1 min and 5 min) after usage of Isoxsuprine hydrochloride as tocolytic agent in the management of preterm labor.Timepoint: Baseline (0 Hour) 24-Hours 48-Hours Time of delivery

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Countries

India

Contacts

Public ContactDr P B Jaju

B. M. Patil Medical College Hospital and Research Centre,

p.b.jaju@gmail.com

Outcome results

None listed

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