Progestagens for the Tertiary Prophylaxis of Preterm Delivery (PROTECT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Modena and Reggio Emilia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01178788
First received: July 8, 2010
Last updated: February 2, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Premature Birth
Neonatal Complications
Drug: 17 alpha-hydroxy progesterone caproate
Drug: micronized Progesterone
Other: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Progestagens for the Tertiary Prophylaxis of Preterm Delivery in Women With Short Cervix. A Randomized Multicentre Trial

Resource links provided by NLM:


Further study details as provided by University of Modena and Reggio Emilia:

Primary Outcome Measures:
  • Preterm delivery (37 weeks of gestation) [ Time Frame: 6 mo. after end of recruitment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delivery <32, <35 wks [ Time Frame: 6 months after the end of the study ] [ Designated as safety issue: No ]
  • Hospital admissions before delivery [ Time Frame: 6 months after the end of the study ] [ Designated as safety issue: Yes ]
  • Gestational age at delivery [ Time Frame: 6 months after the end of the study ] [ Designated as safety issue: No ]
  • Birth-weight centile [ Time Frame: 6 months after the end of the study ] [ Designated as safety issue: No ]
  • NICU admission [ Time Frame: 6 months after the end of the study ] [ Designated as safety issue: No ]
  • days of NICU admission [ Time Frame: 6 months after the end of the study ] [ Designated as safety issue: No ]
  • days of oxygen supply [ Time Frame: 6 months after the end of the study ] [ Designated as safety issue: No ]
  • composite neonatal complications [ Time Frame: 6 months after the end of the study ] [ Designated as safety issue: No ]
    Include: RDS, IVH, ROP, PVL, NEC, Sepsis

  • congenital neonatal anomalies [ Time Frame: 6 months after the end of the study ] [ Designated as safety issue: No ]
  • congenital neonatal malformations [ Time Frame: 6 months after the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: January 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Micronized Progesterone
micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium)
Drug: micronized Progesterone
daily administration of vaginal progesterone
No Intervention: Control
Routine clinical controls
Other: Control
Routine clinical cares as in the remnants two arm using drugs

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178788

Contacts
Contact: Cinzia M Del Giovane, Stat +39059 4223865 Cinzia.delgiovane@unimore.it

Locations
Italy
University of Modena and Reggio Emilia Recruiting
Modena, Italy, 41100
Principal Investigator: Fabio Facchinetti, MD         
Sponsors and Collaborators
University of Modena and Reggio Emilia
Investigators
Study Chair: Fabio Facchinetti, M.D. University of Modena and Reggio Emilia
  More Information

No publications provided

Responsible Party: Fabio Facchinetti, Mother-Infant Dept., University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01178788     History of Changes
Other Study ID Numbers: 2009-017441-63
Study First Received: July 8, 2010
Last Updated: February 2, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Modena and Reggio Emilia:
Progestagens
Tertiary Prophylaxis
Micronized Progesterone
17 alpha hydroxy P
Preterm Delivery
Cervical shortening

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014