17-Alpha hydroxyprogesterone in Multiple pregnancies to Prevent Handicapped InfAnts

ISRCTN	ISRCTN40512715
DOI	https://doi.org/10.1186/ISRCTN40512715
Protocol serial number	N/A
Sponsor	The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)
Funder	The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands) (ref: subsidy 62200019)

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

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

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

Study information

Primary study design	Interventional
Study design	Randomised placebo controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	17-alpha HydroxyProgesterone Caproate
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2011		Yes	No
Protocol article	protocol	19/06/2007		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes