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