Progestagens for the Tertiary Prophylaxis of Preterm Delivery (PROTECT)

September 21, 2016 updated by: Prof. Facchinetti Fabio, University of Modena and Reggio Emilia

Progestagens for the Tertiary Prophylaxis of Preterm Delivery in Women With Short Cervix. A Randomized Multicentre Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: According to the last reviews Progesterone (P) and (17P) are able to reduce preterm delivery (PTD), either as prophylactic administration in the presence of previous PTD or as a treatment of the actual pregnancy, becoming at risk because of cervical shortening/preterm labour. At present is difficult to distinguish the clinical effects of P from the one of 17P as well as it is impossible to choice among the diverse doses and formulations utilized in the RCTs published so far, as well as in those under recruitment.

Protocol: Women will be treated with P, 17P or just clinically observed according to on-line randomization assignment provided by the Methodological Unit. Treatments end at the completion of 36th week. Randomization will be stratified for early (22-27+6th) and late (28-31+6th wks) PTD risk. Interim analysis will be done at 50% enrollment.

Sixty women will be allocated to each Clinical Centre to reach 480 enrollments, in the 3 arms.

Drugs will be provided by manufacturers.

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41100
        • University of Modena and Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 17 alfa hydroxy Progesterone caproate
Women treated with i.m. 17P injection/weekly (Lentogest, IBSA, Italy)
Drug: 17 alpha-hydroxy progesterone caproate
weekly injection of 17 P
Other Names:
  • Lentogest
ACTIVE_COMPARATOR: Micronized Progesterone
micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium)
Drug: micronized Progesterone
daily administration of vaginal progesterone
Other Names:
  • Utrogestan
ACTIVE_COMPARATOR: Control
Routine clinical controls
Procedure: Control
Other Names:
  • Routine clinical cares

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Preterm delivery (37 weeks of gestation)
Time Frame: 6 mo. after end of recruitment
6 mo. after end of recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery <32, <35 wks
Time Frame: 6 months after the end of the study
6 months after the end of the study
Hospital admissions before delivery
Time Frame: 6 months after the end of the study
6 months after the end of the study
Gestational age at delivery
Time Frame: 6 months after the end of the study
6 months after the end of the study
Birth-weight centile
Time Frame: 6 months after the end of the study
6 months after the end of the study
NICU admission
Time Frame: 6 months after the end of the study
6 months after the end of the study
days of NICU admission
Time Frame: 6 months after the end of the study
6 months after the end of the study
days of oxygen supply
Time Frame: 6 months after the end of the study
6 months after the end of the study
composite neonatal complications
Time Frame: 6 months after the end of the study
Include: RDS, IVH, ROP, PVL, NEC, Sepsis
6 months after the end of the study
congenital neonatal anomalies
Time Frame: 6 months after the end of the study
6 months after the end of the study
congenital neonatal malformations
Time Frame: 6 months after the end of the study
6 months after the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Modena and Reggio Emilia

Investigators

  • Study Chair: Fabio Facchinetti, M.D., University of Modena and Reggio Emilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

August 9, 2010

First Posted (ESTIMATE)

August 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 21, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-017441-63

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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