Progestagens for the Tertiary Prophylaxis of Preterm Delivery

NCT01178788 | Completed Phase 3 DMC

• 1 other identifier: 2009-017441-63
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This trial would evaluate the clinical effectiveness of Progesterone(P) and 17-hydroxy Progesterone (17P) in reducing PTD, in symptomatic women at risk because of cervical shortening, in the present pregnancy. Main outcome: Delivery before 37 weeks. Secondary outcomes: Gestational age at delivery, Delivery \<32, \<35 wks, hospital admissions before delivery, birth-weight centile, NICU admission, days of NICU admission, days of oxygen supply, composite neonatal complications, congenital neonatal malformations and anomalies. Allocated treatments will be: Group A: 17P 341 mg i.m./weekly (Lentogest, AMSA, Italy); Group B: micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium) Group C: no treatment, clinical observation Concomitant treatments: Iron and folic acid supplementation, and Betamethasone (12 mg repeated once 24 hours apart) will be permitted. Is not allowed the treatment with tocolytics per os. Any treatment will be recorded. Duration: The period of enrollment is 15 months. Cases not randomized by a clinical unit will be competitively assigned later. Results are expected 20-24 months from starting. Sample Size: hypothesizing a risk of PTD = 0.30 efficacy is defined as a reduction to 50% (risk = 0.15). With a test potency = 0.80 and alpha = 0.025 study needs to enrol 160 patients/arm, with a total of 480 patients. Data analysis: Methodological Unit will assign randomized treatment through a web site and it will collect data through the same way.

Conditions

Preterm Delivery; Neonatal Complications

Keywords

Progestagens; Tertiary Prophylaxis; Micronized Progesterone; 17 alpha hydroxy P; Preterm Delivery; Cervical shortening

Outcome Measures

Primary Outcomes (1)

• Preterm delivery (37 weeks of gestation)

  6 mo. after end of recruitment

Secondary Outcomes (10)

• Delivery <32, <35 wks

  6 months after the end of the study

• Hospital admissions before delivery

  6 months after the end of the study

• Gestational age at delivery

  6 months after the end of the study

• Birth-weight centile

  6 months after the end of the study

• NICU admission

  6 months after the end of the study

Study Arms (3)

17 alfa hydroxy Progesterone caproate

ACTIVE COMPARATOR

Women treated with i.m. 17P injection/weekly (Lentogest, IBSA, Italy)

Drug: 17 alpha-hydroxy progesterone caproate

Micronized Progesterone

ACTIVE COMPARATOR

micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium)

Drug: micronized Progesterone

Control

ACTIVE COMPARATOR

Routine clinical controls

Procedure: Control

Interventions

17 alpha-hydroxy progesterone caproate DRUG

weekly injection of 17 P

Also known as: Lentogest

17 alfa hydroxy Progesterone caproate

micronized Progesterone DRUG

daily administration of vaginal progesterone

Also known as: Utrogestan

Micronized Progesterone

Control PROCEDURE

Also known as: Routine clinical cares

Control

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with singleton pregnancy at 22+0nd to 31+6nd week of gestation presenting with a cervical length ≤25 mm, after an episode of preterm labour.

You may not qualify if:

• Women with previous spontaneous PTD, multiple pregnancy, rupture of membranes, feto-maternal conditions indicating delivery, mullerian malformations, cervical surgery (cervical cerclage etc), presence of regular uterine contractions

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

University of Modena and Reggio Emilia

Modena, 41100, Italy

Location

Related Publications (1)

• Facchinetti F, Vergani P, Di Tommaso M, Marozio L, Acaia B, Vicini R, Pignatti L, Locatelli A, Spitaleri M, Benedetto C, Zaina B, D'Amico R. Progestogens for Maintenance Tocolysis in Women With a Short Cervix: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):64-70. doi: 10.1097/AOG.0000000000002065.

  PMID: 28594783 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

17-alpha-Hydroxyprogesterone; Progesterone; Utrogestan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Fabio Facchinetti, M.D.

  University of Modena and Reggio Emilia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Obstetric-Gynecology Unit

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: August 10, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

IT (1)