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Progestagens for the Tertiary Prophylaxis of Preterm Delivery (PROTECT)

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ClinicalTrials.gov Identifier: NCT01178788
Recruitment Status : Completed
First Posted : August 10, 2010
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Facchinetti Fabio, University of Modena and Reggio Emilia

July 8, 2010
August 10, 2010
September 23, 2016
February 2010
December 2015   (Final data collection date for primary outcome measure)
Preterm delivery (37 weeks of gestation) [ Time Frame: 6 mo. after end of recruitment ]
Same as current
Complete list of historical versions of study NCT01178788 on ClinicalTrials.gov Archive Site
  • Delivery <32, <35 wks [ Time Frame: 6 months after the end of the study ]
  • Hospital admissions before delivery [ Time Frame: 6 months after the end of the study ]
  • Gestational age at delivery [ Time Frame: 6 months after the end of the study ]
  • Birth-weight centile [ Time Frame: 6 months after the end of the study ]
  • NICU admission [ Time Frame: 6 months after the end of the study ]
  • days of NICU admission [ Time Frame: 6 months after the end of the study ]
  • days of oxygen supply [ Time Frame: 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
  • congenital neonatal anomalies [ Time Frame: 6 months after the end of the study ]
  • congenital neonatal malformations [ Time Frame: 6 months after the end of the study ]
Same as current
Not Provided
Not Provided
 
Progestagens for the Tertiary Prophylaxis of Preterm Delivery
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Preterm Delivery
  • Neonatal Complications
  • Drug: 17 alpha-hydroxy progesterone caproate
    weekly injection of 17 P
    Other Name: Lentogest
  • Drug: micronized Progesterone
    daily administration of vaginal progesterone
    Other Name: Utrogestan
  • Procedure: Control
    Other Name: Routine clinical cares
  • Active Comparator: 17 alfa hydroxy Progesterone caproate
    Women treated with i.m. 17P injection/weekly (Lentogest, IBSA, Italy)
    Intervention: Drug: 17 alpha-hydroxy progesterone caproate
  • Active Comparator: Micronized Progesterone
    micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium)
    Intervention: Drug: micronized Progesterone
  • Active Comparator: Control
    Routine clinical controls
    Intervention: Procedure: Control
Facchinetti F, Vergani P, Di Tommaso M, Marozio L, Acaia B, Vicini R, Pignatti L, Locatelli A, Spitaleri M, Benedetto C, Zaina B, DʼAmico 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
254
480
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01178788
2009-017441-63
Yes
Not Provided
Not Provided
Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
University of Modena and Reggio Emilia
Not Provided
Study Chair: Fabio Facchinetti, M.D. University of Modena and Reggio Emilia
University of Modena and Reggio Emilia
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP