Plain English Summary

Not provided at time of registration

Trial website

http://www.studies-obsgyn/ppromexil

Contact information

Type

Scientific

Primary contact

Dr Christine Willekes

ORCID ID

Contact details

P. Debijelaan 25
Maastricht
6202 AZ
Netherlands
+31 (0)43 387 4768
cwi@sgyn.azm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5521

Study information

Scientific title

Acronym

PPROMEXIL

Study hypothesis

The aim of this study is to solve the dilemma for the obstetric gynaecologist regarding the optimal treatment of women with Preterm Premature Rupture Of the Membranes (PPROM) after 34 weeks of gestation. Therefore, we will compare the effectiveness of induction of labour after PPROM between 34 and 37 weeks gestation compared to expectant monitoring on neonatal infection. Also, cost effectiveness and quality of life is measured in both treatment arms and compared.

Ethics approval

Ethical approval received from the Medical Ethical Committee of the University Hospital Maastricht on the 3rd March 2006 (ref: MEC 05-240.5/fh).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Premature rupture of the membranes

Intervention

Induction of labour versus expectant management

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Neonatal sepsis

Secondary outcome measures

1. Maternal morbidity (chorioamnionitis/sepsis)
2. Respiratory Distress Syndrome (RDS)
3. Neonatal disease
4. Instrumental delivery rate
5. Quality of life and costs

Overall trial start date

01/01/2007

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Pregnant women with PPROM at a gestational age from 34 + 0/7 until 37 weeks who have given informed consent.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

520

Participant exclusion criteria

1. Foetal distress
2. Major foetal anomalies
3. Meconium stained amniotic fluid
4. Maternal infection at entry
5. Monochorionic Diamniotic (MCDA) multiple pregnancy
6. Multiple pregnancy, first child breech presentation
7. Previous caesarean section
8. Diabetes mellitus (defined as use of insulin)
9. Renal disease (inluding Systemic Lupus Erythematosus [SLE])
10. Seropositive for Human Immunodeficiency Virus (HIV)
11. Haemolysis, Elevated Liver, Low Platelet (HELLP)/severe pre-eclampsia
12. Oliguria less than 500 ml/24 hours

Recruitment start date

01/01/2007

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

P. Debijelaan 25
Maastricht
6202 AZ
Netherlands

Sponsor information

Organisation

The Netherlands Organisation 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 Organisation for Health Research and Development (ZonMw) (The Netherlands)

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/17617892
2. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22545024
3. 2014 economic analysis results in: http://www.ncbi.nlm.nih.gov/pubmed/24392746

Publication citations

  1. Protocol

    van der Ham DP, Nijhuis JG, Mol BW, van Beek JJ, Opmeer BC, Bijlenga D, Groenewout M, Arabin B, Bloemenkamp KW, van Wijngaarden WJ, Wouters MG, Pernet PJ, Porath MM, Molkenboer JF, Derks JB, Kars MM, Scheepers HC, Weinans MJ, Woiski MD, Wildschut HI, Willekes C, Induction of labour versus expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks (the PPROMEXIL-trial)., BMC Pregnancy Childbirth, 2007, 7, 11, doi: 10.1186/1471-2393-7-11.

  2. Results

    van der Ham DP, Vijgen SM, Nijhuis JG, van Beek JJ, Opmeer BC, Mulder AL, Moonen R, Groenewout M, van Pampus MG, Mantel GD, Bloemenkamp KW, van Wijngaarden WJ, Sikkema M, Haak MC, Pernet PJ, Porath M, Molkenboer JF, Kuppens S, Kwee A, Kars ME, Woiski M, Weinans MJ, Wildschut HI, Akerboom BM, Mol BW, Willekes C, , Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial., PLoS Med., 2012, 9, 4, e1001208, doi: 10.1371/journal.pmed.1001208.

  3. Economic analysis results

    Vijgen SM, van der Ham DP, Bijlenga D, van Beek JJ, Bloemenkamp KW, Kwee A, Groenewout M, Kars MM, Kuppens S, Mantel G, Molkenboer JF, Mulder AL, Nijhuis JG, Pernet PJ, Porath M, Woiski MD, Weinans MJ, van Wijngaarden WJ, Wildschut HI, Akerboom B, Sikkema JM, Willekes C, Mol BW, Opmeer BC, , Economic analysis comparing induction of labor and expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks (PPROMEXIL trial)., Acta Obstet Gynecol Scand, 2014, 93, 4, 374-381, doi: 10.1111/aogs.12329.

Editorial Notes