Table 2.

WHO trial registration data set

Primary registry and trial identifying number	Trial NL6623 (NTR6953)
Date of registration in primary registry	28 December 2017
Secondary identifying numbers	n/a
Source(s) of monetary or material support	ZonMW Dutch Healthcare efficacy programme
Primary sponsor	Academical Medical Centre, Amsterdam, The Netherland
Secondary sponsor(s)	n/a
Contact for public queries	Drs. Noor Simons Follow-up.ppromexil@amsterdamumc.nl
Contact for scientific queries	Prof. dr. Eva Pajkrt e.pajkrt@amsterdamumc.nl
Public title	PPROMEXIL Follow-up
Scientific title	Child outcomes after induction of labour or expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks of gestation: the PPROMEXIL Follow-up trial, a long-term follow-up study of the randomised controlled trials PPROMEXIL and PPROMEXIL-2.
Countries of recruitment	The Netherlands
Health condition(s) or problem(s) studied	Late preterm prelabour rupture of membranes (PROM between 34+0 and 36+6 weeks gestational age). Long-term effects of induction of labour versus expected management.
Intervention(s)	n/a
Key inclusion and exclusion criteria	The PPROMEXIL Follow-up trial will analyse children of mothers with a singleton pregnancy (induction of labour n=359; expectant management n=352). At 10–12 years of (corrected) age all surviving children will be invited for follow-up.
Study type	Follow-up of a randomised controlled trial
Date of first enrolment	3 August 2018
Sample size	All sample size calculations are with a power of 90%, a two-sided α of 0.05 and ß of 0.20. To be able to detect a clinically relevant difference in mean scores of 0.5 SD in all tests, 86 children per group will be sufficient (total 172 children). This 0.5 SD equals a difference of 7.5 IQ points in the mean score of the WISC-V test (cognitive development), a difference of 1.5 points on the mean total standard scores of the M-ABC-2 (motor skills) and a difference of 5 points on the mean T scores in any of the broadband problem scales of the Child Behaviour Checklist, CBCL (behavioural development) between both groups. Thus, since 172 children comprise 24% of our total, also in case of limited follow-up, differences of 0.5 SD can be picked up.
Recruitment status	Open for patient inclusion
Primary outcome(s)	Cognitive development (WISC-V) Motor skills (Movement-ABC-2) Behaviour (CBCL).
Key secondary outcomes	Academic attainment and behaviour (Teacher Report Form) Sensory processing (Short Sensory Profile) Respiratory problems (International Study of Asthma and Allergies in Childhood questionnaire) Pubertal status (Puberty Developmental Scale) Height, weight, bloodpressure General health and demographics (questionnaires)
Ethics review	The Medical Ethics Committee of the Academic Medical Centre Amsterdamhas approved the PPROMEXIL Follow-up trial (METC 2016_217, NL58494.018.16).
Completion date	n/a
Summary results	n/a
IPD sharing statement	n/a

IPD, individual participant data; n/a, not available; WISC-V, Wechsler Intelligence Scale for Children.