17-Alpha hydroxyprogesterone in Multiple pregnancies to Prevent Handicapped InfAnts

ISRCTN ISRCTN40512715
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

Study website

Contact information

Prof HW Bruinse
Scientific

Lundlaan 6
P.O.Box 85090
Utrecht
3508 AB
Netherlands

Phone +31 (0)30 2504000
Email H.W.Bruinse@umcutrecht.nl

Study information

Study designRandomised placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study acronymAMPHIA
Study objectivesProphylactic 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) studiedMultiple pregnancy
InterventionParticipants 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)17-alpha HydroxyProgesterone Caproate
Primary outcome measureThe 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 measuresSecondary 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 date01/08/2006
Completion date01/02/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants700
Key inclusion criteria1. Women with a multiple pregnancy
2. Gestational age between 15 and 19 weeks
3. Aged 18 and older
Key exclusion criteria1. 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 enrolment01/08/2006
Date of final enrolment01/02/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Lundlaan 6
Utrecht
3508 AB
Netherlands

Sponsor information

The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)
Research organisation

PO Box 93245
Den Haag
2509 AE
Netherlands

Website http://www.zonmw.nl
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 19/06/2007 Yes No
Results article results 01/09/2011 Yes No