Addendum

Uitgebreide beschrijving van gekozen uitkomstmaten.

Relevante uitkomstmaten

De gedefinieerde uitkomstmaten zijn gebaseerd op een tweetal bronnen: de uitkomstenmaten zoals deze gedefinieerd zijn in de Cochrane-review aangaande dit onderwerp en de uitkomstmaten zoals deze gedefinieerd zijn in het COPOP-project (hieronder verder toegelicht). Daarnaast zijn de uitkomstenmaten met betrekking tot vervolgzwangerschap ten behoeve van deze richtlijnmodule toegevoegd.

Het COPOP-project (core outcomes for studies on primary prevention of preterm birth) is opgezet om een core outcome set te definiëren om wereldwijd alle studies dezelfde uitkomstmaten te laten rapporteren. Het betreft een samenwerking tussen:

Global Obstetrics Network (GONet, Ongoing pessary trials)

Journal Editors (CROWN; core outcomes in women’s health)

Core Outcome Measures in Effectiveness Trials (COMET)

Cochrane Collaboration on preterm birth

World Health Organization (WHO)

Patient Organizations

Midwifery Organizations

http://www.crown-initiative.org/

In onderstaande tabel zijn alle uitkomstmaten samengevat uit de verschillende bronnen. In de voetnoot is te lezen uit welke bron elke uitkomst afkomstig is. Op basis van deze tabel is zijn uiteindelijk de kritieke en belangrijke uitkomstmaten vastgesteld.

Maternal set of outcomes short term	Proposed definition
Maternal mortality`	1. Maternal death yes/no to be captured at 28 days post EDD
Maternal infection or inflammation`	2. Genital tract infection requiring treatment? Yes/no at any time after randomization Postpartum endometritis or pelvic infection? Yes /no Wound infection (caesarean scare or episiotomy / vaginal sutures) requiring treatment? Yes/no to be captured up to 28 days post partum^
Harm to mother from intervention* Not further specified`*	Caesarean section: planned and emergency General anesthesia Regional anesthesia Instrumental vaginal delivery Post partum heamorrhage (TBL>500ml), bloodtransfusion Thromboembolism (diep veneus, longembolie, sinus sagittalis, vena ovarica)? Treated with therapeutic anticoagulants therapy Yes/no to be captured up to 28 days post partum^ Intensive care unit admission Women not satisfied with care Urinary retention requiring bladder catheter > 24hours longer as local protocol prescribes^

Longer-term maternal outcomes (at three months)*	Proposed definition
	Breastfeeding failure, as defined by trial authors; perineal pain; abdominal pain; backache or back pain; any pain; dyspareunia, as defined by trial authors; uterovaginal prolapse; urinary incontinence; flatus incontinence; faecal incontinence; postnatal depression, as defined by trial authors; postnatal self-esteem, as defined by trial authors; postnatal anxiety, as defined by trial authors; relationship with baby, as defined by trial authors; relationship with partner, as defined by trial authors.

Long-term maternal outcomes (at two years)*	Proposed definition
	Breastfeeding failure, as defined by trial authors; perineal pain; abdominal pain; backache or back pain; any pain; dyspareunia, as defined by trial authors; uterovaginal prolapse; urinary incontinence; flatus incontinence; faecal incontinence; irregular bleedings^ infertility; subsequent pregnancy; miscarriage or termination of a subsequent pregnancy; time to subsequent ongoing pregnancy (>12 weeks GA)^ preterm delivery (<36 weeks) in subsequent pregnancy^ caesarean section in a subsequent pregnancy; uterine rupture in a subsequent pregnancy; placenta increta / percreta in a subsequent pregnancy^ stillbirth (>16 weeks GA) in a subsequent pregnancy^ perinatal mortality (up to 28 days post EDD) in a subsequent pregnancy^ dysmenorrhoea; menorrhagia; postnatal depression, as defined by trial authors postnatal self-esteem, as defined by trial authors; postnatal anxiety, as defined by trial authors; relationship with child, as defined by trial authors; relationship with partner, as defined by trial authors. Satisfaction with mode of delivery during breech birth^

Bron: Janneke van ’t Hooft, Crown collaborative group; *Cochrane review- Hofmeyr 2015; ^Added by F. Vlemmix; outcomes related to subsequent pregnancies

Fetal / neonatal set of outcomes short term		Proposed definition
Offspring mortality’		Death of birth / fetal death. Reported as the AD at which fetal death was diagnosed after randomization Neonatal death within 28 days post EDD
Offspring infection’		Proven early sepsis within 72 hours after birth proven by positive blood, CSF or urine (catheterized) culturs
Gestational age at birth’		Date of birth compared to EDD
Harms to offspring from intervention’
Birth weight’		Birth weight
Early neurodevelopmental morbidity’		Bilateral PVL (includes bilateral cystic PVL (Periventricular leukomalacia, common in children with cerebral palsy))’ IVH grad III /IV, IVH with ventricular dilatation or parenchymal extension confirmed by MRI/CT/sonogram’ Seizures* Neonatal encephalopathy*
Apgar-score*		Less than 7 at 5 minutes Less than 4 at 5 minutes
Cord blood*		cord blood pH less then 7.2; cord blood pH less than 7.0; base deficit at least 15;
Birth trauma*		birth trauma, as defined by trial authors brachial plexus injury.
NICU admission*		neonatal intensive care unit admission

Neonatal set of outcomes long term		Proposed definition
Death*		Death (excluding fatal anomalies);
Disability in childhood*		disability in childhood, as defined by trial authors;
Other medical problems*		medical problems as defined by authors

Bron: Janneke van ’t Hooft, Crown collaborative group; *Cochrane review-Hofmeyr 2015;

De werkgroep achtte ‘offspring mortality; perinatale mortaliteit’, ‘maternal mortality; maternale mortiliteit’ en ‘disability in childhood; morbiditeit op kinderleeftijd’ (en als indirect bewijs hiervoor een 5 minuten Apgar-score <4 en navelstrengbloed pH<7.0) voor de besluitvorming kritieke uitkomstmaten; en, ‘maternal morbidity; maternale morbiditeit’, ‘uterine rupture in subsequent pregnancy; uterus ruptuur in vervolgzwangerschap’, ‘perinatal mortality in subsequent pregnancy; perinatale sterfte in vervolgzwangerschap’ en ‘maternal mortality in subsequent pregnancy; maternale sterfte in vervolgzwangerschap’ voor de besluitvorming belangrijke uitkomstmaten.