Efficacy of Oral Progesterone and Vaginal Progesterone After Tocolytic Therapy in Threatened Preterm Labor

NCT02989519 | Completed Phase 3

• 1 other identifier: SPS2016-01
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine efficacy of vaginal and oral progesterone after tocolytic therapy in threatened preterm labor

Conditions

Preterm Delivery

Keywords

preterm labor; progesterone efficacy; threatened preterm labor

Outcome Measures

Primary Outcomes (1)

• preterm delivery before 34 and 37 weeks

  3 months

Secondary Outcomes (1)

• change of cervical length

  2 weeks

Study Arms (3)

no progesterone

NO INTERVENTION

All women with preterm labor underwent standard tocolysis, which was administered for at least 48 hours, to allow corticosteroid promote fetal lung maturation

oral progesterone

EXPERIMENTAL

All women with preterm labor underwent standard tocolysis, which was administered for at least 48 hours, to allow corticosteroid promote fetal lung maturation. All women in this arm received oral progesterone (dydrogesterone 10 mg; Duphaston™) per oral three times a day

Drug: dydrogesterone

vaginal progesterone

EXPERIMENTAL

All women with preterm labor underwent standard tocolysis, which was administered for at least 48 hours, to allow corticosteroid promote fetal lung maturation. All women in this arm received vaginal progesterone (micronized progesterone 200 mg; Utrogestan™) at bed time.

Drug: Micronized progesterone

Interventions

dydrogesterone DRUG

Also known as: Duphaston

oral progesterone

Micronized progesterone DRUG

Also known as: Utrogestan

vaginal progesterone

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Single pregnancies of 28 to 33 weeks and 6 days who had been experienced for threatened or preterm labor with intact membrane

You may not qualify if:

• Proven membranes ruptured
• Ultrasonographically found placenta previa, multiple pregnancy, fetal anomaly
• Aneuploidy detected.
• Had emergency condition that required for emergency delivery such as fetal distress, chorioamnionitis, prolapsed cord

Sponsors & Collaborators

• Sanpasitthiprasong Hospital: lead

Study Sites (1)

Piyawadee Wuttikonsammakit

Nai Muang, Changwat Ubon Ratchathani, 34000, Thailand

Location

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature

Interventions

Dydrogesterone; Progesterone; Utrogestan

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Piyawadee Wuttikonsammakit, MD

  Instructor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 12, 2016
• Study Start: August 1, 2015
• Primary Completion: January 5, 2017
• Study Completion: March 1, 2017
• Last Updated: October 10, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)