Condition category
Pregnancy and Childbirth
Date applied
02/11/2006
Date assigned
04/01/2007
Last edited
06/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.studies-obsgyn.nl/amphia

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 measures

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

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

http://www.zonmw.nl

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes