NCT02430233

Brief Summary

Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2018

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
3.6 years until next milestone

Study Start

First participant enrolled

December 19, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2023

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

4.2 years

First QC Date

April 20, 2015

Last Update Submit

February 27, 2023

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (2)

  • The mean number of days from enrollment to delivery

    Up to 18 weeks

  • The rate of preterm spontaneous delivery

    defined as spontaneous labor or preterm delivery following induction/cesarean section due to preterm premature rupture of membranes prior to 37 weeks of gestation

    Up to 13 weeks

Secondary Outcomes (16)

  • Number of days from recruitment to repeated preterm labor episode or preterm premature rupture of membranes, up to 37 weeks of gestation

    Up to 13 weeks

  • Pregnancy prolongation beyond one week

    Up to 18 weeks

  • Need for repeated acute tocolysis

    Up to 13 weeks

  • Number of hospitalizations and length of stay until 36.6 gestational weeks

    Up to 13 weeks

  • The rate of preterm spontaneous labor (defined as spontaneous labor or preterm premature rupture of membranes prior to 37 weeks of gestation)

    Up to 13 weeks

  • +11 more secondary outcomes

Study Arms (2)

micronized progesterone 400 mg

EXPERIMENTAL

participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)

Drug: micronized progesterone 400 mg (Utrogestan)

No treatment

NO INTERVENTION

No treatment

Interventions

micronized progesterone 400 mg (Utrogestan)DRUG

participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)

Also known as: Utrogestan- 200mg×2 PV(per vagina) per day
micronized progesterone 400 mg

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Tocolytic treatment between 24+0 and 34+0 weeks
  • Patient's consent to participate in this study
  • hours after tocolytic initiation and up to 3 days after finishing the tocolytic treatment
  • Arrest of preterm labor

You may not qualify if:

  • Contraindication to ongoing pregnancy including:
  • Suspected amnionitis during testing for eligibility- evidence of active infection including temperature ≥ 38.0°C and uterine tenderness, foul-smelling vaginal discharge, maternal tachycardia of 120 beats per minute or greater, or sustained fetal tachycardia of 160 beats per minute or greater
  • Evidence of significant placental abruption (contractions and significant bleeding from placental origin)
  • Intrauterine fetal death diagnosed at the time of admission
  • Major fetal malformation
  • Known maternal allergy to progesterone
  • Current use of progesterone at the time of admission
  • Epilepsy
  • Breast cancer
  • PPROM (preterm premature rupture of membranes) during testing for eligibility
  • Age below 18 years
  • Known active liver disease (elevated liver enzymes at twice the upper normal limit according to medical history or blood test that were taking doring standard medical care)
  • History of deep vein thrombosis
  • Major active psychiatric disorders (major affective disorders and psychotic disorders)
  • Uncontrolled chronic hypertension
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Poriya Medical Center

Tiberias, North, 15208, Israel

Location

Emek Medical center

Afula, Please Select, 18100, Israel

Location

Assuta Ashdod medical center

Ashdod, Israel

Location

Related Publications (1)

  • Nachum Z, Ganor Paz Y, Massalha M, Wated M, Harel N, Yefet E. Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419894. doi: 10.1001/jamanetworkopen.2024.19894.

    PMID: 38976270DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

ProgesteroneUtrogestan

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 30, 2015

Study Start

December 19, 2018

Primary Completion

February 27, 2023

Study Completion

February 27, 2023

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations

IL(3)