Comparison of two different vaginal preparations of progesterone for prevention of recurrent preterm birth: A Randomized Controlled Trial

Comparison of two vaginal preparations of micronized progesterone for prevention of recurrent preterm birth (effervescent vaginal tablet and gelatin capsule): A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/048696

Enrollment

Registered

2023-01-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Health Condition 1: O092- Supervision of pregnancy with other poor reproductive or obstetric history

Interventions

Intervention1: 200 milligrams of micronized progesterone effervescent vaginal tablet: The effervescent vaginal tablet, contains progesterone in a base of sodium bicarbonate, and an acid-base reaction

Eligibility

Inclusion criteria

Inclusion criteria: 1. Singleton live pregnancy between 16 to 20 weeks. 2. At least one spontaneous mid-trimester abortion or preterm birth (>=16 weeks PoG to

Exclusion criteria

Exclusion criteria: 1.Multifetal gestation 2.Known allergy to progesterone 3.Women with medical disorders (severe chronic hypertension, diabetes mellitus, heart disease, severe anaemia, collagen vascular disorders) which require additional treatment or may result in Preterm delivery 4.Major congenital malformation of the fetus. 5.Women with short cervical length ( 6.Women with current cerclage

Design outcomes

Primary

Measure	Time frame
To compare micronized progesterone effervescent vaginal tablet with micronized progesterone gelatin capsule used vaginally, for prevention of PTB less than 37 weeks, in women with a prior spontaneous PTB or a mid-trimester abortion.Timepoint: Till the delivery	—

Secondary

Measure	Time frame
1 To compare the incidence of PTB less than and equal to 32 weeks (very PTB) and less than and equal to 28 weeks (extreme PTB) in the above two groups Timepoint: Preterm delivery less than and equal to 32 weeks and 28 weeks respectively;To compare the acceptability and tolerability of the two progesterone formulations Timepoint: At least 15 days after using the progesterone formulations and later whenever the women complain	—

Measure

Time frame

1 To compare the incidence of PTB less than and equal to 32 weeks (very PTB) and less than and equal to 28 weeks (extreme PTB) in the above two groups Timepoint: Preterm delivery less than and equal to 32 weeks and 28 weeks respectively;To compare the acceptability and tolerability of the two progesterone formulations Timepoint: At least 15 days after using the progesterone formulations and later whenever the women complain

—

Countries

India

Contacts

Public ContactDr Divya Chopra

Post Graduate Institute of Medical Education and Reearch

rashmibagga@gmail.com9872494602

Outcome results

None listed

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