Overview
Sponsor-declared trial summary
Placenta previa, preterm birth
1. To assess the effectiveness of progesterone - started between 18- and 24-weeks of gestation, compared to no treatment - in the prevention of preterm birth in women with a placenta previa. We will assess total preterm birth rates and rates subdivided in spontaneous and iatrogenic preterm birth at different gestationa…
Key facts
- Sponsor
- Amsterdam UMC
- Participant type
- Pediatric, Patients
- Age range
- In Utero, 0-17 years, 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 21 May 2024 → ongoing
- Decision date (initial)
- 2024-02-16
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507763-18-01
- WHO UTN
- U1111-1295-4225
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Prophylaxis
1. To assess the effectiveness of progesterone - started between 18- and 24-weeks of gestation, compared to no treatment - in the prevention of preterm birth in women with a placenta previa. We will assess total preterm birth rates and rates subdivided in spontaneous and iatrogenic preterm birth at different gestational age cut-offs, duration of pregnancy, neonatal mortality and morbidity, and maternal side effects. 2. The primary outcome measure will be the relative risk of preterm birth before 37 weeks of gestation.
Secondary objectives 1
- Secondary outcomes will be the relative risk of preterm birth before 34 weeks of gestation, and preterm births will also be assessed as spontaneous and indicated separately for different cut-offs (28, 32, 34 and 37 weeks of gestation). Neonatal outcomes will be a composite adverse neonatal outcome for neonatal morbidity and neonatal mortality, and components will also be assessed separately. Maternal outcomes will be maternal morbidity and side effects, and (indication for chosen) mode of birth.
Conditions and MedDRA coding
Placenta previa, preterm birth
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Intervention group Study participants in the intervention arm will be treated with 200 mg Utrogestan, once daily, ante noctem. The study medication (Utrogestan) will not be labeled.
|
Randomised Controlled | None | Control group: The control group will receive expectant management as is currently standard practice. |
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-507763-18-00 | Progesterone for prEventing Preterm births in women with PlacEnta pRevia (PEPPER-trial) | Amsterdam UMC |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Women pregnant of a singleton – without any other high-risk factor for preterm birth - diagnosed with a placenta previa diagnosed between 18- and 24 weeks of gestation.
Exclusion criteria 1
- 1. Multiple pregnancy, 2. Major fetal congenital and/or chormosomal abnormalities, 3. Cervical cerclage or pessary in situ or planned to be placed, 4. Cervical dilation ≥ 3cm, 5. Intra-uterine fetal death, 6. Women with an already existing indication for progesterone use per current guidelines, 7. (Suspected) placenta accreta spectrum disorder, 8. Contra-indication for progesterone use, 9. Inability to give informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of PTB before 37 weeks of gestation
Secondary endpoints 1
- 1. sPTB/iPTB <37wks, 2. PTB >24wks, 3. Total PTB, sPTB, iPTB <28/32/34wks, 4. Mean gestational age, 5. Incidence of <10th/3rd percentile birthweight, 6. Umbilical cord blood pH (arterial/venous), 7. Apgar <7 at 5 mins, 8. NICU admissions (>24 hrs, hrs in NICU), 9. Components of composite outcome, 10. Planned/unplanned CS, 11. Admission for antenatal blood loss (incidence), 12. Threatened preterm birth (incidence).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP145363 · ATC
- Active substance
- Progesterone
- Route of administration
- VAGINAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 25200 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC
- Sponsor organisation
- Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC
- Contact name
- Prof. Dr. E. Pajkrt
Public contact point
- Organisation
- Amsterdam UMC
- Contact name
- Prof. Dr. E. Pajkrt
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 142 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-05-21 | 2024-05-21 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-26 | Netherlands | Acceptable 2024-02-16
|
2024-02-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-14 | Netherlands | Acceptable 2024-02-16
|
2024-03-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-28 | Netherlands | Acceptable | 2024-06-26 |