The CORONIS Follow-up Study is funded by the UK Medical Research Council and DfID and is following-up women recruited to the CORONIS Trial (a multicentre international fractional factorial unmasked randomised controlled trial).
The trial recruited 15,935 women between 2007 and 2010.
The Follow-up Study aims to measure and compare the incidence of outcomes at 'three years' and is being conducted in hospitals in the following seven countries where recruitment to the CORONIS Trial was carried out: Argentina, Chile, Ghana, India, Kenya, Pakistan and Sudan.
These countries have experience in detailed follow-up of large numbers of women.
Women will have a face-to-face interview at least three years post-discharge to assess long-term maternal morbidity and infant mortality outcomes including: the proportion of women with no subsequent pregnancy (both voluntary and involuntary); pelvic pain, dyspareunia, laparoscopy, hysterectomy (not related to pregnancy), incisional hernia; infant mortality.
And for women having any subsequent pregnancy: the inter-pregnancy interval; miscarriage; multiple pregnancy; gestation at delivery; vaginal birth after caesarean; other pregnancy complications including uterine rupture, uterine scar dehiscence, placenta praevia, placenta accreta, postpartum endometritis, caesarean or postpartum hysterectomy, manual removal of placenta.
The long-term assessment of women began in September 2011 and is planned to end in June 2015.