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Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

A Randomized, Double Blinded, Placebo Controlled Trial of Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02262481
Enrollment
48
Registered
2014-10-13
Start date
2014-08-31
Completion date
2015-06-30
Last updated
2016-01-28

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

Conditions

Preterm Labor

Brief summary

The purpose of this study is to evaluate the effect of oral progesterone supplementation in preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy period, and its side effect.

Interventions

DRUGdydrogesterone
DRUGplacebo

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Singleton pregnancy * Preterm labor * GA24-34wk * Intact membranes

Exclusion criteria

* Maternal/fetal condition requiring immediate delivery ex. Chorioamnionitis, fetal distress * Placenta previa * medical and obstetric complications * allergy to dydrogesterone

Design outcomes

Primary

MeasureTime frame
The recurrence of uterine contraction within 48 hours after stop tocolytic48 hours

Secondary

MeasureTime frame
Gestational age at delivery9 weeks
Number of newborn with respiratory distress syndrome9 weeks
side effects9 weeks
Time from preterm labor pain to delivery9 weeks
Number of newborn with necrotizing enterocolitis9 weeks
Number of newborn with sepsis9 weeks
Number of newborn with intraventricular hemorrhage9 weeks

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026