Preterm DeliveryPhase 3PROTECTNCT01178788
Progestagens for the Tertiary Prophylaxis of Preterm Delivery
A Phase 3 study testing 17 alpha-hydroxy progesterone caproate and micronized Progesterone in people with Preterm Delivery and Neonatal Complications, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Delivery, Neonatal Complications
- What is being tested?
- 17 alpha-hydroxy progesterone caproate and micronized Progesterone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2010to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Preterm Delivery, Neonatal Complications
- Being tested
- 17 alpha-hydroxy progesterone caproate, micronized Progesterone, Control
- Keywords
- Progestagens, Tertiary Prophylaxis, Micronized Progesterone, 17 alpha hydroxy P, Preterm Delivery, Cervical shortening
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17 alpha-hydroxy progesterone caproateDrug
Also called Lentogest
weekly injection of 17 P
micronized ProgesteroneDrug
Also called Utrogestan
daily administration of vaginal progesterone
ControlProcedure or surgery
Also called Routine clinical cares
| Study group | Role | What they receive |
|---|---|---|
| 17 alfa hydroxy Progesterone caproate | Active comparator | Women treated with i.m. 17P injection/weekly (Lentogest, IBSA, Italy) Receives: Drug: 17 alpha-hydroxy progesterone caproate |
| Micronized Progesterone | Active comparator | micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium) Receives: Drug: micronized Progesterone |
| Control | Active comparator | Routine clinical controls Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm delivery (37 weeks of gestation)
Measured: 6 mo. after end of recruitment
Secondary outcomes (10)
Delivery <32, <35 wks
Measured: 6 months after the end of the study
Hospital admissions before delivery
Measured: 6 months after the end of the study
Gestational age at delivery
Measured: 6 months after the end of the study
Birth-weight centile
Measured: 6 months after the end of the study
NICU admission
Measured: 6 months after the end of the study
days of NICU admission
Measured: 6 months after the end of the study
days of oxygen supply
Measured: 6 months after the end of the study
composite neonatal complications
Include: RDS, IVH, ROP, PVL, NEC, Sepsis
Measured: 6 months after the end of the study
congenital neonatal anomalies
Measured: 6 months after the end of the study
congenital neonatal malformations
Measured: 6 months after the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
- Investigators
- Fabio Facchinetti, M.D., Study chair, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178788
- Sponsor's protocol ID
- 2009-017441-63
- Other IDs
- 2009
- Acronym
- PROTECT
- Status last verified
- Sep 2016
- First submitted
- 8 Jul 2010
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28594783
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progestagens for the Tertiary Prophylaxis of Preterm Delivery in Women With Short Cervix. A Randomized Multicentre Trial
- ClinicalTrials.gov ID
- NCT01178788
- Acronym / sponsor ID
- PROTECT / 2009-017441-63
- Conditions
- Preterm Delivery, Neonatal Complications
- Keywords
- Progestagens, Tertiary Prophylaxis, Micronized Progesterone, 17 alpha hydroxy P, Preterm Delivery, Cervical shortening
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 17 alfa hydroxy Progesterone caproate | Active comparator | Drug: 17 alpha-hydroxy progesterone caproateWomen treated with i.m. 17P injection/weekly (Lentogest, IBSA, Italy) |
| Micronized Progesterone | Active comparator | Drug: micronized Progesteronemicronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium) |
| Control | Active comparator | Procedure: ControlRoutine clinical controls |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17 alpha-hydroxy progesterone caproateAlso: Lentogestweekly injection of 17 P | Drug | 17 alfa hydroxy Progesterone caproate |
| micronized ProgesteroneAlso: Utrogestandaily administration of vaginal progesterone | Drug | Micronized Progesterone |
| ControlAlso: Routine clinical cares | Procedure or surgery | Control |
Primary outcome
Preterm delivery (37 weeks of gestation)
Time frame: 6 mo. after end of recruitment
10 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Derived from this study: PubMed 28594783Facchinetti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Facchinetti, M.D. study chair
University of Modena and Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 17 alpha-hydroxy progesterone caproate and micronized Progesterone in people with Preterm Delivery and Neonatal Complications, run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm delivery (37 weeks of gestation) (time frame: 6 mo. after end of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01178788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.