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Comparison of two ways of delivering a drug (progesterone) to prevent another preterm delivery, one by an injection and other through the vagina

Comparison of vaginal and intramuscular routes of progesterone delivery in prevention of preterm delivery in women with prior preterm birth

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/01/005467
Enrollment
100
Registered
2015-01-27
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- Pregnant patients with a prior spontaneous preterm birth or mid trimester abortion

Interventions

Intervention1: Progesterone Vaginal Tablet: 200 mg of natural micronised progesterone (vaginal tablet) daily from enrolment (16-24 weeks) to 37 weeks PoG or Delivery. Control Intervention1: Intramuscu

Sponsors

Postgraduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women with a singleton pregnancy between 16 to 24 weeks 2. Women with at least one spontaneous second trimester abortion or preterm birth ( >16 weeks to

Exclusion criteria

Exclusion criteria: 1. Multifetal Gestation 2. Known allergy to progesterone. 3. Women with known medical disorders (Chronic Hypertension, Diabetes mellitus, heart disease) which may need preterm delivery 4. Lethal congenital malformation of the fetes

Design outcomes

Primary

MeasureTime frame
Incidence of preterm birth less than 37 weeks in the two groups receiving vaginal and intramuscular progesteroneTimepoint: Till December 2013—

Secondary

MeasureTime frame
Neonatal outcome in the two groupsTimepoint: Till Discharge;Incidence of episodes of preterm labour in the two groupsTimepoint: Till 34 weeks Gestation;Incidence of preterm birth 34 weeks and 28 weeks in the two groups receiving vaginal or intramuscular pogesteroneTimepoint: Till December 2013—

Countries

India

Contacts

Public ContactShruti Shambhavi

PGIMER

rashmibagga@gmail.com9872494602

Outcome results

None listed

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