Study procedures
We performed a randomized controlled trial (RCT) at a gynaecological department in a tertiary level teaching hospital in Cape Town, South Africa, and five affiliated community healthcare centres (CHCs) in the Cape Town metropolitan area. Eligible women were ≥18 years old, undergoing medical abortion, between 17 and 20 GW, opting and eligible for the copper IUD as post-abortion contraception. Women were informed about the study during a group contraceptive counselling session prior to their clinical evaluation at the outpatient department. They were enrolled to the study after screening for eligibility and a private written informed consent process. The research design did not involve patient-public engagement.
A research group not directly involved in study procedures generated the randomization sequence 1:1 in random permuted blocks of 4-6 and prepared sequential sealed envelopes which were delivered to the research team by hand and stored in a locked box. Two field workers performed the randomization allocation face to face with the participant after she was admitted to the gynaecological ward. The nature of the study did not permit blinding of study staff, clinical providers or participants. Between August 2018 and June 2019 we enrolled 114 women, undergoing MA between 17-20 GW with a combined mifepristone-misoprostol regimen. Prior to this, three women were enrolled to pilot study procedures.
For participants allocated to the immediate arm, clinicians planned to insert the IUD within 24 hours of completion of the abortion and prior to discharge from the gynaecological ward. The IUD was inserted by the on-call physician in an exam room in the ward or in the operating theatre if manual removal of the placenta or a vacuum aspiration for retained placenta was required. The IUD was not inserted in cases of prolonged rupture of membranes (>18 hours), excessive bleeding, or signs of infection. If the patient developed a contraindication to immediate insertion, she crossed over to the delayed arm. Women in the delayed arm were referred for insertion at their referral CHC 3 weeks after the abortion. Until then they were provided 4 weeks of oral contraceptive pills. Delayed insertion was scheduled for 3 weeks post-abortion, an evidence-based protocol, and not 6 weeks as is standard practice in South Africa in order to increase compliance with the appointment.9 The IUD was inserted by a reproductive health nurse certified in abortion care and IUD insertion.
Participants were scheduled for an in-person follow-up visit including an ultrasound examination 6 weeks after the abortion with the study clinician at the tertiary hospital outpatient department. Non-returnees were contacted by phone. Two subsequent follow-up interviews took place by phone at 3 and 6 months. Participants were reminded 3 times by message and voice call to follow-up with study appointments. Those who could not be reached after this were visited at their home address. Participants received R300 compensation for in-person study visits and telephone airtime of R150 for each completed phone interview (total