17-Alpha hydroxyprogesterone in Multiple pregnancies to Prevent Handicapped InfAnts
ISRCTN | ISRCTN40512715 |
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DOI | https://doi.org/10.1186/ISRCTN40512715 |
Secondary identifying numbers | N/A |
- Submission date
- 02/11/2006
- Registration date
- 04/01/2007
- Last edited
- 06/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof HW Bruinse
Scientific
Scientific
Lundlaan 6
P.O.Box 85090
Utrecht
3508 AB
Netherlands
Phone | +31 (0)30 2504000 |
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H.W.Bruinse@umcutrecht.nl |
Study information
Study design | Randomised placebo controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Prevention |
Scientific title | |
Study acronym | AMPHIA |
Study objectives | Prophylactic administration of 17-alpha HydroxyProgesterone Caproate (17OHPC) will reduce the incidence of the composite neonatal morbidity of neonates by reducing the early preterm birth rate in multiple pregnancies. |
Ethics approval(s) | Approval received from the local ethics committee (MEC AMC Amsterdam) on November 30th 2005, (reference number: 05/102). |
Health condition(s) or problem(s) studied | Multiple pregnancy |
Intervention | Participants will receive weekly intramuscular injections of 17OHPC or placebo, starting at a gestational age between 16 and 20 weeks and continuing until 36 weeks. Cervical length will be measured at time of randomisation. Further pregnancy and labour management will be according to local protocol. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 17-alpha HydroxyProgesterone Caproate |
Primary outcome measure | The primary outcome will be composite neonatal morbidity, containing severe Respiratory Distress Syndrome (RDS), BronchoPulmonal Dysplasia (BPD), intraventricular haemorrhage stage IIB or worse, Necrotising EnteroColitis (NEC), proven sepsis and death before discharge. |
Secondary outcome measures | Secondary outcome measures are: 1. Time to delivery 2. Preterm birth rate before 32 and 37 weeks 3. Days of admission in neonatal intensive care unit 4. Maternal morbidity 5. Maternal admission days for preterm labour 6. Costs |
Overall study start date | 01/08/2006 |
Completion date | 01/02/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 700 |
Key inclusion criteria | 1. Women with a multiple pregnancy 2. Gestational age between 15 and 19 weeks 3. Aged 18 and older |
Key exclusion criteria | 1. Major congenital anomaly of (one of) the fetuses 2. Death of (one of) the fetuses 3. Early signs of Twin-to-Twin Transfusion Syndrome 4. Primary cerclage 5. Previous preterm birth less than 34 weeks |
Date of first enrolment | 01/08/2006 |
Date of final enrolment | 01/02/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Lundlaan 6
Utrecht
3508 AB
Netherlands
3508 AB
Netherlands
Sponsor information
The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)
Research organisation
Research organisation
PO Box 93245
Den Haag
2509 AE
Netherlands
Website | http://www.zonmw.nl |
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https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands) (ref: subsidy 62200019)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Protocol article | protocol | 19/06/2007 | Yes | No | |
Results article | results | 01/09/2011 | Yes | No |