Open Access Study protocol

Preventing preterm birth with progesterone: costs and effects of screening low risk women with a singleton pregnancy for short cervical length, the Triple P study

Melanie A van Os1*, Jeanine A van der Ven2, C Emily Kleinrouweler2, Eva Pajkrt2, Esteriek de Miranda2, Aleid van Wassenaer3, Martina Porath4, Patrick M Bossuyt5, Kitty WM Bloemenkamp6, Christine Willekes7, Mallory Woiski8, Martijn A Oudijk9, Katia M Bilardo10, Marko J Sikkema11, Johannes J Duvekot12, Diederik Veersema13, Jacqueline Laudy14, Petra Kuiper15, Christianne JM de Groot1, Ben Willem J Mol2 and Monique C Haak6

  • * Corresponding author: Melanie A van Os m.vanos@vumc.nl

  • † Equal contributors

Author Affiliations

1 Department of Obstetrics and Gynaecology, VU Medical Centre, Amsterdam, the Netherlands

2 Department of Obstetrics and Gynaecology, Academic Medical Centre Amsterdam, the Netherlands

3 Department of Neonatology, Emma Children's Hospital Academic Medical Centre, Amsterdam, the Netherlands

4 Department of Obstetrics and Gynaecology, Máxima Medisch Centrum, Veldhoven, the Netherlands

5 Department of Clinical Epidemiology, Academic Medical Centre, Amsterdam, the Netherlands

6 Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands

7 Department of Obstetrics and Gynaecology, Academic Hospital, Maastricht, Maastricht, the Netherlands

8 Department of Obstetrics and Gynaecology, Radboud University, Nijmegen, the Netherlands

9 Department of Obstetrics and Gynaecology, University Medical Centre, Utrecht, the Netherlands

10 Department of Obstetrics and Gynaecology, University Medical Centre, Groningen, the Netherlands

11 Department of Obstetrics and Gynaecology, ZHT, Almelo, the Netherlands

12 Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, the Netherlands

13 Diagnostiek voor u diagnostisch centrum, Eindhoven, the Netherlands

14 Star Medisch Diagnostisch Centrum, Rotterdam, the Netherlands

15 Ultrasound centre FARA, Ede, the Netherlands

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BMC Pregnancy and Childbirth 2011, 11:77  doi:10.1186/1471-2393-11-77

Published: 24 October 2011

Abstract

Background

Women with a short cervical length in mid-trimester pregnancy have a higher risk of preterm birth and therefore a higher rate of neonatal mortality and morbidity. Progesterone can potentially decrease the number of preterm births and lower neonatal mortality and morbidity. Previous studies showed good results of progesterone in women with either a history of preterm birth or a short cervix. However, it is unknown whether screening for a short cervix and subsequent treatment in mid trimester pregnancy is effective in low risk women.

Methods/Design

We plan a combined screen and treat study among women with a singleton pregnancy without a previous preterm birth. In these women, we will measure cervical length at the standard anomaly scan performed between 18 and 22 weeks. Women with cervical length ≤ 30 mm at two independent measurements will be randomly allocated to receive either vaginal progesterone tablets or placebo between 22 and 34 weeks. The primary outcome of this trial is adverse neonatal condition, defined as a composite outcome of neonatal mortality and severe morbidity. Secondary outcomes are time to delivery, preterm birth rate before 32, 34 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We will assess growth, physical condition and neurodevelopmental outcome of the children at two years of age.

Discussion

This study will provide evidence for the usefulness and cost-effectiveness of screening for short cervical length at the 18-22 weeks and subsequent progesterone treatment among low risk women.

Trial registration

Netherlands Trial Register (NTR): NTR207