Clinical trial • Other

progesterone for Placenta previa | Preterm birth

Clinical trial of progesterone for Placenta previa | Preterm birth.

Overview

Trial Therapeutic Area
Other
Trial Disease
Placenta previa | Preterm birth
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
26-10-2023
First CTIS Authorization Date
16-02-2024

Trial design

Randomised, open-label, intervention arm: utrogestan (progesterone) 200 mg, vaginal, once daily, ante noctem. control group: expectant management (standard practice, no treatment). trial across 9 sites in Netherlands.

Randomised
Yes
Open Label
Yes
Comparator
Intervention arm: Utrogestan (progesterone) 200 mg, vaginal, once daily, ante noctem. Control group: expectant management (standard practice, no treatment).
Target Sample Size
142

Eligibility

Recruits 142 Vulnerable population selected: pregnant women. Exclusion includes "Inability to give informed consent". No further details on assent/consent procedures or age-specific consent documents are provided in the record..

Pregnancy Exclusion
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
Vulnerable Population
Vulnerable population selected: pregnant women. Exclusion includes "Inability to give informed consent". No further details on assent/consent procedures or age-specific consent documents are provided in the record.

Inclusion criteria

  • {"criterion_text":"- 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

  • {"criterion_text":"- 1. Multiple pregnancy\n- 2. Major fetal congenital and/or chormosomal abnormalities\n- 3. Cervical cerclage or pessary in situ or planned to be placed\n- 4. Cervical dilation ≥ 3cm\n- 5. Intra-uterine fetal death\n- 6. Women with an already existing indication for progesterone use per current guidelines\n- 7. (Suspected) placenta accreta spectrum disorder\n- 8. Contra-indication for progesterone use\n- 9. Inability to give informed consent"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of PTB before 37 weeks of gestation","definition_or_measurement_approach":"Primary outcome measured as the number (and relative risk) of preterm births before 37 weeks of gestation comparing progesterone started between 18 and 24 weeks versus no treatment."}

Secondary endpoints

  • {"endpoint_text":"- 1. sPTB/iPTB <37wks\n- 2. PTB >24wks\n- 3. Total PTB, sPTB, iPTB <28/32/34wks\n- 4. Mean gestational age\n- 5. Incidence of <10th/3rd percentile birthweight\n- 6. Umbilical cord blood pH (arterial/venous)\n- 7. Apgar <7 at 5 mins\n- 8. NICU admissions (>24 hrs, hrs in NICU)\n- 9. Components of composite outcome\n- 10. Planned/unplanned CS\n- 11. Admission for antenatal blood loss (incidence)\n- 12. Threatened preterm birth (incidence).","definition_or_measurement_approach":"Measured as incidence counts and comparative measures (relative risk) between intervention and control. Endpoints are assessed at specified gestational age cut-offs (e.g., <28/32/34/37 weeks), neonatal composite outcomes assessed both as composite and individual components, and clinical measures (Apgar, cord pH, NICU admission) recorded per standard clinical definitions."}

Recruitment

Planned Sample Size
142
Recruitment Window Months
48
Consent Approach
Informed consent is required from participants (pregnant women); exclusion includes those with "Inability to give informed consent." No further details on assent, age-specific documents, or languages available are provided in the record.

Geography

Total Number Of Sites
9
Total Number Of Participants
142

Netherlands

Earliest CTIS Part Ii Submission Date
22-01-2024
Latest Decision Or Authorization Date
26-06-2024
Processing Time Days
156
Number Of Sites
9
Number Of Participants
142

Sites

Site Name
Noordwest Ziekenhuisgroep Stichting
Department Name
Gynaecology
Contact Person Name
Joost Velzel
Contact Person Email
j.velzel@nwz.nl
Site Name
Flevoziekenhuis Stichting
Department Name
Gynaecology
Contact Person Name
J.M. Schaaf
Site Name
Rode Kruis Ziekenhuis B.V.
Department Name
Gynaecology
Contact Person Name
Janneke Leijnse
Contact Person Email
jleijnse@rkz.nl
Site Name
Zaans Medisch Centrum Stichting
Department Name
Gynaecology
Contact Person Name
Yolanda de Mooij
Contact Person Email
mooij.y@zaansmc.nl
Site Name
Dijklander Ziekenhuis
Department Name
Gynaecology
Contact Person Name
F Vlemmix
Contact Person Email
DOC@dijklander.nl
Site Name
OLVG Stichting
Department Name
Gynaecology
Contact Person Name
Jiska de Haan-Jebbink
Contact Person Email
j.m.dehaan-jebbink@olvg.nl
Site Name
Academisch Medisch Centrum
Department Name
Gynaecology
Contact Person Name
E. Pajkrt
Contact Person Email
e.pajkrt@amsterdamumc.nl
Site Name
Tergooiziekenhuizen
Department Name
Gynaecology
Contact Person Name
B.A.M. Braams-Lisman
Contact Person Email
pgyna1@tergooi.nl
Site Name
Spaarne Gasthuis
Department Name
Gynaecology
Contact Person Name
Karlijn Vollebregt

Sponsor

Primary sponsor

Full Name
Amsterdam UMC
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
PROGESTERONE
Active Substance
progesterone
Modality
Small molecule
Routes Of Administration
Vaginal
Route
Vaginal
Starting Dose
200 mg
Dose Levels
200 mg
Frequency
Once daily, ante noctem
Maximum Dose
200 mg

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