Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof HW Bruinse
ORCID ID
Contact details
Lundlaan 6
P.O.Box 85090
Utrecht
3508 AB
Netherlands
+31 (0)30 2504000
H.W.Bruinse@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
AMPHIA
Study hypothesis
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
Approval received from the local ethics committee (MEC AMC Amsterdam) on November 30th 2005, (reference number: 05/102).
Study design
Randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
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 names
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 trial start date
01/08/2006
Overall trial end date
01/02/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women with a multiple pregnancy
2. Gestational age between 15 and 19 weeks
3. Aged 18 and older
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
700
Participant 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
Recruitment start date
01/08/2006
Recruitment end date
01/02/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Lundlaan 6
Utrecht
3508 AB
Netherlands
Sponsor information
Organisation
The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)
Sponsor details
PO Box 93245
Den Haag
2509 AE
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands) (ref: subsidy 62200019)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17578562
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21860279
Publication citations
-
Protocol
Lim AC, Bloemenkamp KW, Boer K, Duvekot JJ, Erwich JJ, Hasaart TH, Hummel P, Mol BW, Offermans JP, van Oirschot CM, Santema JG, Scheepers HC, Schöls WA, Vandenbussche FP, Wouters MG, Bruinse HW, , Progesterone for the prevention of preterm birth in women with multiple pregnancies: the AMPHIA trial., BMC Pregnancy Childbirth, 2007, 7, 7, doi: 10.1186/1471-2393-7-7.
-
Results
Lim AC, Schuit E, Bloemenkamp K, Bernardus RE, Duvekot JJ, Erwich JJ, van Eyck J, Groenwold RH, Hasaart TH, Hummel P, Kars MM, Kwee A, van Oirschot CM, van Pampus MG, Papatsonis D, Porath MM, Spaanderman ME, Willekes C, Wilpshaar J, Mol BW, Bruinse HW, 17α-hydroxyprogesterone caproate for the prevention of adverse neonatal outcome in multiple pregnancies: a randomized controlled trial., Obstet Gynecol, 2011, 118, 3, 513-520, doi: 10.1097/AOG.0b013e31822ad6aa.