Preterm DeliveryPhase 2NCT00329914
Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?
A Phase 2 study testing Progesterone in people with Preterm Delivery, run by Copenhagen University Hospital, Rigshospitalet at 17 sites in 2 countries.
Trial summary
The purpose of the study is to determine whether a daily dose of 200 mg progesterone administered vaginally from 20-23 to 34 weeks' gestation will reduce the rate of preterm delivery amongst twin pregnancies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Delivery
- What is being tested?
- Progesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 677 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Jun 2006to Sep 2010
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Twin pregnancy
- Informed consent
- 18-23 weeks' gestation
- Participants must be fluent in the language spoken in the respective centres
Who cannot join
- Age < 18 years
- Known allergy to progesterone or peanuts
- Active thromboembolic disorders or a history of hormone-associated thromboembolic disorders
- Rupture of membranes at the time of inclusion
- Monoamniotic twins
- Pregnancies treated for or with signs of twin-to-twin transfusion syndrome at inclusion
Show all 11Show fewer
- Multiple pregnancies reduced to twin pregnancies
- Known significant structural or chromosomal fetal abnormality
- Chorionicity not assessed before 15 weeks
- Known or suspected malignancy in genitals or breasts
- Known liver disease
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Denmark13 sites
Aalborg Hospital
Aalborg, 9100
Skejby Hospital
Aarhus, 8200
Rigshospitalet
Copenhagen, 2100
Glostrup Hospital
Glostrup Municipality, 2600
Gentofte Hospital
Hellerup, 2900
Herlev Hospital
Herlev, 2730
Hilleroed Hospital
Hilleroed, 3400
Holbaek Hospital
Holbæk, 4300
Hvidovre Hospital
Hvidovre, 2650
Odense University Hospital
Odense, 5000
Roskilde Hospital
Roskilde, 4000
Soenderborg Hospital
Sønderborg, 6400
Viborg Hospital
Viborg, 8800
Austria4 sites
Graz University Hospital
Graz, 8036
Innsbruck University Hospital
Innsbruck, 6020
Klagenfurt Hospital
Klagenfurt, 9020
Vienna University Hospital
Vienna, 1090
About this study
Official title: Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial
The purpose of the study is to determine whether a daily dose of 200 mg progesterone administered vaginally from 20-23 to 34 weeks' gestation will reduce the rate of preterm delivery amongst twin pregnancies.
Read the detailed description
Multiple gestations account for 2% of all pregnancies, but cause more than 10% of the cases of preterm delivery. Due to increasing maternal age and use of assisted reproduction the number of multiple gestations is larger than ever. If markers of preterm delivery can be identified and means of preventing preterm delivery are found, it will be possible to reduce the number of children admitted to hospital because of prematurity.
Recently, two larger randomised studies investigated the effect of progesterone in singleton pregnancies of women who had previously delivered preterm. They both found a significant reduction in the preterm delivery rate in the progesterone group compared to a placebo group.
The study will be performed as a randomized, double-blind placebo controlled study of twin pregnancies in Denmark and Austria. The women will be randomised in a 1:1 ratio to two groups (progesterone versus placebo). Randomisation will be stratified per centre and according to chorionicity, as the risk of preterm delivery is doubled in monochorionic twins compared to dichorionic twins.
- Conditions
- Preterm Delivery
- Being tested
- Progesterone, Placebo
- Keywords
- Preterm delivery, Prevention, Twins, Progesterone
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Also called Utrogestan
Vaginal pessaries, 200 mg/day
PlaceboDrug
Placebo pessaries containing peanut oil
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Progesterone | Active comparator | Not described Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of delivery < 34 weeks, in the study group versus the control group
Measured: Participants will be followed until 3 weeks after delivery
Secondary outcomes (5)
Physical and neurological development of the children at 6 and 18 months
Measured: 2 years after delivery
The relationship between cervical length and prophylactic progesterone treatment
Measured: Participants will be followed until 3 weeks after delivery
Determination of proteomics and RNA in preterm delivery and term delivery and an evaluation of the effect of progesterone on proteomics and RNA
Measured: Participants will be followed until 3 weeks after delivery
Assessment of the potential anti-inflammatory effect of progesterone by cytokine-measurements
Measured: Participants will be followed until 3 weeks after delivery
Assessment of the effect of progesterone on CRH-levels in twin pregnancies
Measured: Participants will be followed until 3 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startJun 2006
- Primary completionFeb 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 677 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council, The Danish Medical Society in Copenhagen, AP Moeller Foundation
- Investigators
- Line Rode, MD, Principal investigator, Ultrasound Clinic 4002, RigshospitaletAnn Tabor, professor, Study director, Ultrasound Clinic 4002, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329914
- Sponsor's protocol ID
- predict2006
- Status last verified
- Feb 2009
- First submitted
- 24 May 2006
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rode L, Klein K, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Prevention of preterm delivery in twin gestations (PREDICT): a multicenter, randomized, placebo-controlled trial on the effect of vaginal micronized progesterone. Ultrasound Obstet Gynecol. 2011 Sep;38(3):272-80. doi: 10.1002/uog.9093.
PubMed 21739497Klein K, Rode L, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Vaginal micronized progesterone and risk of preterm delivery in high-risk twin pregnancies: secondary analysis of a placebo-controlled randomized trial and meta-analysis. Ultrasound Obstet Gynecol. 2011 Sep;38(3):281-7. doi: 10.1002/uog.9092.
PubMed 21739499Rode L, Klein K, Larsen H, Holmskov A, Andreasen KR, Uldbjerg N, Ramb J, Bodker B, Skibsted L, Sperling L, Hinterberger S, Krebs L, Zingenberg H, Weiss EC, Strobl I, Laursen L, Christensen JT, Skogstrand K, Hougaard DM, Krampl-Bettelheim E, Rosthoj S, Vogel I, Tabor A. Cytokines and the risk of preterm delivery in twin pregnancies. Obstet Gynecol. 2012 Jul;120(1):60-8. doi: 10.1097/AOG.0b013e31825bc3cd.
PubMed 22914392
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial
- ClinicalTrials.gov ID
- NCT00329914
- Acronym / sponsor ID
- predict2006
- Conditions
- Preterm Delivery
- Keywords
- Preterm delivery, Prevention, Twins, Progesterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 677 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council, The Danish Medical Society in Copenhagen, AP Moeller Foundation
- Study start
- Jun 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 25 May 2006 (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.
The purpose of the study is to determine whether a daily dose of 200 mg progesterone administered vaginally from 20-23 to 34 weeks' gestation will reduce the rate of preterm delivery amongst twin pregnancies.
Detailed description
Multiple gestations account for 2% of all pregnancies, but cause more than 10% of the cases of preterm delivery. Due to increasing maternal age and use of assisted reproduction the number of multiple gestations is larger than ever. If markers of preterm delivery can be identified and means of preventing preterm delivery are found, it will be possible to reduce the number of children admitted to hospital because of prematurity.
Recently, two larger randomised studies investigated the effect of progesterone in singleton pregnancies of women who had previously delivered preterm. They both found a significant reduction in the preterm delivery rate in the progesterone group compared to a placebo group.
The study will be performed as a randomized, double-blind placebo controlled study of twin pregnancies in Denmark and Austria. The women will be randomised in a 1:1 ratio to two groups (progesterone versus placebo). Randomisation will be stratified per centre and according to chorionicity, as the risk of preterm delivery is doubled in monochorionic twins compared to dichorionic twins.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Progesterone | Active comparator | Drug: Progesterone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Twin pregnancy
- Informed consent
- 18-23 weeks' gestation
- Participants must be fluent in the language spoken in the respective centres
Key exclusion criteria (11 listed)
- Age < 18 years
- Known allergy to progesterone or peanuts
- Active thromboembolic disorders or a history of hormone-associated thromboembolic disorders
- Rupture of membranes at the time of inclusion
- Monoamniotic twins
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 |
|---|---|---|
| ProgesteroneAlso: UtrogestanVaginal pessaries, 200 mg/day | Drug | Progesterone |
| PlaceboPlacebo pessaries containing peanut oil | Drug | Placebo |
Primary outcome
The incidence of delivery < 34 weeks, in the study group versus the control group
Time frame: Participants will be followed until 3 weeks after delivery
5 secondary outcomes
Physical and neurological development of the children at 6 and 18 months
Time frame: 2 years after delivery
The relationship between cervical length and prophylactic progesterone treatment
Time frame: Participants will be followed until 3 weeks after delivery
Determination of proteomics and RNA in preterm delivery and term delivery and an evaluation of the effect of progesterone on proteomics and RNA
Time frame: Participants will be followed until 3 weeks after delivery
Assessment of the potential anti-inflammatory effect of progesterone by cytokine-measurements
Time frame: Participants will be followed until 3 weeks after delivery
Assessment of the effect of progesterone on CRH-levels in twin pregnancies
Time frame: Participants will be followed until 3 weeks after delivery
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 25 Jul 2011.
- Results publication: PubMed 21739497Rode L, Klein K, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Prevention of preterm delivery in twin gestations (PREDICT): a multicenter, randomized, placebo-controlled trial on the effect of vaginal micronized progesterone. Ultrasound Obstet Gynecol. 2011 Sep;38(3):272-80. doi: 10.1002/uog.9093.
- Results publication: PubMed 21739499Klein K, Rode L, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Vaginal micronized progesterone and risk of preterm delivery in high-risk twin pregnancies: secondary analysis of a placebo-controlled randomized trial and meta-analysis. Ultrasound Obstet Gynecol. 2011 Sep;38(3):281-7. doi: 10.1002/uog.9092.
- Derived from this study: PubMed 22914392Rode L, Klein K, Larsen H, Holmskov A, Andreasen KR, Uldbjerg N, Ramb J, Bodker B, Skibsted L, Sperling L, Hinterberger S, Krebs L, Zingenberg H, Weiss EC, Strobl I, Laursen L, Christensen JT, Skogstrand K, Hougaard DM, Krampl-Bettelheim E, Rosthoj S, Vogel I, Tabor A. Cytokines and the risk of preterm delivery in twin pregnancies. Obstet Gynecol. 2012 Jul;120(1):60-8. doi: 10.1097/AOG.0b013e31825bc3cd.
- Related InfoLink provided by the sponsor.
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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.
Line Rode, MD principal investigator
Ultrasound Clinic 4002, Rigshospitalet
Ann Tabor, professor study director
Ultrasound Clinic 4002, Rigshospitalet
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Progesterone in people with Preterm Delivery, run by Copenhagen University Hospital, Rigshospitalet at 17 sites in 2 countries.
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 4 inclusion and 11 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 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Denmark, Austria. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The incidence of delivery < 34 weeks, in the study group versus the control group (time frame: Participants will be followed until 3 weeks after delivery). 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 NCT00329914, which also lists 3 linked publications.
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 25 Jul 2011.