Randomized controlled trial main outcomes
The RCT intention to treat (ITT) analysis included 112 women, 55 and 57 in the immediate (I) and delayed (D) arms respectively. By ITT, 82% (I) and 21% (D) of women received the IUD as planned in the study. At 6 weeks 56% (I) and 19% (D) were using the original IUD and 76% (I) and 40% (D) were using either the original, a replacement or a newly placed IUD. Two women has recurrent pregnancies within the 6 months trial follow-up period, both followed the delayed protocol. There were no serious adverse events.
Process Evaluation Findings
Delivery of the trial protocol - Fidelity and dose
Five women crossed over from the immediate to the delayed group after the abortion due to excessive bleeding, prolonged placental retention or suspected infection. Of these, 3 were provided with 1 months’ supply of oral contraceptives, (OCs) as per study protocol, and 2 were given the 3-month injectable progestin contraceptive in deviation of protocol. There were 13 further protocol deviations: in the immediate group 2 changed their mind about the IUD after the abortion in favour of an injectable method, and 1 was given the injectable contraceptive in error. In the delayed group 10 were given the 3-month injectable contraceptive in place of OCs.
We identified four main themes and twelve subsidiary categories to these themes.
1. Perspectives on the IUD and timing of insertion after medical abortion.
a. Preferences for immediate versus delayed insertion of the IUD
b. Barriers to immediate insertion of the IUD
c. Mechanisms to support immediate insertion of the IUD
2. Follow-up: Continuity of care and women’s decisions at follow-up.
a. Continuity of care following abortion
b. Women’s decisions regarding the IUD during follow-up
3. Impact of study procedures on perceptions, behaviour and outcomes.
a. Group contraceptive counselling- effect on IUD uptake and women´s experiences
c. WhatsApp communication doctor’s group
d. Communications between study staff and participants
e. Impact of trial on participant or provider behaviour
4. Contextual factors impacting on trial outcomes.
a. Staff shortages infrastructure and resource constraints
b. Women’s perceptions of primary healthcare services
Theme 1: Perspectives on timing for IUD insertion after medical abortion.
Women’s and staff perspectives on the best time to start with the IUD after medical abortion were informed by personal and clinical factors such as convenience, time saved, and contraceptive effectiveness.
Preferences for immediate versus delayed insertion of the IUD
Women generally described a preference for immediate insertion. Some from the delayed group felt the 3-week delay would place them at risk of pregnancy, place additional demands on their time, and involve additional costs which meant they might not go for IUD insertion. This was echoed by providers. Preference for immediate insertion was expressed by two participants as follows.
“well I was so stressed when I found out that I couldn’t put the IUD immediately because I thought what if in this process while I’m waiting for this IUD, what if something happened, coz it’s very hard for us as married woman to use protection, specially to our husbands because they get to ask the questions….” (Immediate group, crossover to delayed, IUD inserted at 6weeks by study clinician)
“I felt happy, I didn’t have a problem that I was going to have it inserted because I wanted to have it inserted immediately, because I already heard how it works and just thought that if it works out for immediately, then I should have it inserted immediately and not waste time.”(Immediate group, IUD expulsed and replaced at 6 weeks)
The increased efficiency of immediate insertion was expressed by a resident doctor as follows;
“I think in terms of making sure it gets used, immediate insertion is easier for the woman and it cuts out one follow up visit which makes it easier to put in and use and I think to come back 6 weeks later for an insertion and then come back another 6 weeks later for a string check is very labour intensive. Whereas if it is put in at the time, it’s in, she’s more likely to use it and it just avoids second follow up”. (Resident doctor, hospital)
Barriers to immediate insertion of the IUD
Although most healthcare providers considered immediate insertion a better option, they noted that staffing issues, specifically timely availability of providers competent to perform the IUD insertion and contraindications to immediate insertion could be barriers to an effective service.
One senior nursing sister expressed this as follows:
“only 1 registrar who is working the weekend, she has an emergency, she has theatre that she must take up, she has 2 wards that she must look after. And then apparently there’s this patient that is waiting to go home, panicking because (the IUD insertion) it’s not done, …….so if they delaying and all of that and she’s done, she would rather take an injection or something else because the patient wants to go home”. (Sister in charge of ward, hospital)
Mechanisms to enable immediate insertion of the IUD
To resolve staff shortages and lack of training, some healthcare staff suggested having a dedicated trained midwife to provide abortion and post-abortion care or alternatively training interns to do the IUD insertions as this should be within their competency and they would be more available.
“I think it would be solved by having a, a qualified nurse or qualified midwife, just one person who’s responsible for this stream of care and then that would also mean that these patients can go home on the same day” (Study clinician)
“I think it would have been helpful if the interns was maybe trained to have done it because there’s more interns than registrars”. (Ward operations manager, hospital)
Theme 2: Follow up: Continuity of care and women’s decisions at follow-up.
Continuity of care following abortion
In the study´s immediate arm protocol the abortion and postabortion care are rendered at the same place and by a provider familiar with the woman´s reproductive history which meant she need not explain herself to a new healthcare provider:
“I mean, a great benefit is that women actually get the IUD inserted. And I think there’s a second advantage because once women have it and are sort of in the system, they are also more likely to come back to their follow up, at least if you provide continuity of care. If you can offer that, women stay in the fold, you have a relationship and you say come back see me, I know your story, I know you’ve had an abortion, there’s no problem with that, then I don’t think they’re as reluctant to come back for a check-up”. (Study clinician)
Women’s decisions regarding the IUD during study follow-up
In the RCT, 82% in the immediate and 21% in the delayed arm had the IUD inserted as planned. Despite a moderately high rate of partial expulsion which required removal of the original IUD in the immediate group, most of these women requested a replacement IUD. Some women in the delayed group asked for an IUD at the 6-week follow up even if they did not go to the CHF for insertion as planned. Thus, at 6 weeks 76% and 40% of women in the immediate versus delayed arm respectively, were using the original, a replacement or a newly placed IUD. Among the women in the delayed arm who did not have the IUD inserted as planned, many reverted to short term methods they had used before.
One woman who requested an IUD replacement at 6 weeks because the original IUD was malpositioned said the following:
“of course, I did have some problems after I put the IUD……she said to me, it’s low. Do you want us to take it right now, we put it right now or you want us to make another appointment). Then I said no, if you’ve got a chance you can do it now because I was already on a bed. And then it was not sore anywhere honestly, and then I decided immediately, take it out and put the new one.(Immediate group, IUD malpositioned, replaced at 6 weeks)
Another woman was planned for insertion at 3 weeks, but the provider was not available – she requested insertion at her 6-week follow-up; she described what happened as follows:
“I went to the clinic but the lady that was implanting the IUD wasn’t there, so that’s why I didn’t put it in, they gave me the injection for 3 months and they said I must come back January…. But I call the lady from [hospital name] and said, and she said it’s fine, I can come, they will do it for me there…... (Delayed group; IUD inserted at 6 weeks by study clinician)
A woman in the delayed group changed her mind about the IUD but completed her follow-up interviews by phone. She explained her decision for the injectable method as being concerned about the possibility of expelling the device, not noticing it and becoming pregnant again.
“Yes, that while I have it in, it might fall out and what if I’m not as lucky as the others where when it falls out, they see it in their panties, and I don’t see it and then I continue to have sex and then fall pregnant again, thinking that it’s still in there whereas it had fallen out a long time ago.” (Delayed group; injectable on discharge, no IUD at 6weeks, 3 months or 6 months)
Many women who had the IUD inserted subsequently expressed happiness with the method and feelings of autonomy and liberation.
‘this IUD, it’s quite good to me. I do not have even any cramps; my menstruation periods are normal. I do not have even any problem with it, it is fine, to me it’s fine. I just like it, I’m not using anything, I can’t even feel it, I can’t even feel anything except when I put a finger inside for me to, to check. Yes, that’s when I feel it you know inside. But it’s as normal fine” (Immediate, got IUD as planned, IUD in situ throughout)
“ooh I felt really, I’m, I’m so happy, I feel free and stress free. I didn’t, I don’t have anything to worry about. About like kids, uh huh, the ones I have now it’s fine, so I’m free, safe and free (Delayed group, IUD placed at 6 weeks by study clinician)
Theme 3: Impact of supplementary activities on trial processes
Effect of counselling on IUD uptake and experience
Women reported that the counselling supported contraception decision-making by providing information, encouragement, and reassurance which had a positive effect on IUD uptake and continuation. For instance, a participant noted:
“I took her word for it and I tried it and it’s still working for me. She convinced me that it is a better option because she understands how I feel when I told her about the other ones I was on” (Immediate group, IUD expulsed and replaced at 6 weeks)
Training of providers
The need for competence and confidence in IUD insertion was a recurring theme expressed by providers, and emerged directly from the supplementary trial activities, notably the IUD insertion training sessions. These had a positive impact on motivation to provide immediate IUD insertion as expressed by one provider:
“well, I think if we had a session like that, we’d definitely be more confident in putting in the IUD and ja, I think it would improve the number of patients getting IUDs on time. I did do the training session that we had, and I’d been putting them in before that, but it was a nice refresher, I felt more confident after that” (Resident doctor, hospital)
Effect of WhatsApp alerts to insert the IUD
Providers considered the WhatsApp group a good mechanism to remind each other about patients needing the IUD inserted, especially on weekends, but also feared it may not be sustainable.
“I mean she’s getting a TOP and she needs an IUD. So, she [the study clinician] would usually remind you the day before and especially on the weekends, I think it was really, really helpful because you wouldn’t know that whether there’s a TOP in the, in the ward or not coz they’re totally closed off from everyone else” (Resident doctor, hospital)
Communication between IUD study staff and women
Communications by voice and text message from the study staff about follow-up were perceived positively by study participants. Women said this communication helped them buffer emotional difficulties and that it made them feel more informed and comfortable about using the IUD. They also noted that communication with the study staff seemed genuine and was non-condemnatory. One participant expressed this as follows:
“when they phone me, they phone me and then they ask me nicely, they not rude by the phone, they not forcing, like you must be there because you have that – it’s a must, you must be there. They first arrange, how can we get you, will you be available any day, give us a date that you’re going to be available, we can be available for you. That’s another thing that makes me happy” (Immediate group, IUD in situ at 6 weeks)
Impact of trial processes on participant or provider behaviour
Providers generally thought that the trial processes were unlikely to have significantly influenced the RCT main outcomes, namely use and correct placement of the IUD 6 weeks after TOP. However, they noted the increased follow up at 6weeks among both study groups compared to usual and linked this to the compensation participants received for completing study visits and interviews
“it could have been compensation…. I might not be 100% sure but definitely I think that it’s mostly for the compensation. You must understand that most of, of our clients, I mean R100 means a lot to them”. (Operations manager, abortion service, CHC)
Theme 4: Contextual impacts on trial findings
Resource constraints and staff shortages
Lack of availability of resources was a frustration expressed by healthcare staff and a potential barrier to providing the IUD immediately after the abortion, as expressed by two different doctors:
“it’s uncomplicated, it’s fairly easy. The only difficulty is just getting the necessary equipment…. And then at the beginning of the study, we also had a struggle with the instruments until they make a plan of getting their own instruments”. (Resident doctor, hospital)
“I think there might be opposition from people because they see it as an extra job or chore to do, just because it takes more time than writing up a script for Petogen or the pill. But I don’t think that should be a reason why it’s not implemented” (Resident doctor, hospital)
Women’s perceptions of primary healthcare services
Women explained reluctance to attend CHCs for follow-up because they feared facing a judgmental attitude on the part of healthcare providers. They also noted that waiting times at clinics were long and some described being turned away more than once.
“Like for example, going to the local clinics, sisters will ask you, ask you why, what happened, why you making abortion, you know this thing – like they will make you feel bad about doing it and, which is unprofessional, they not supposed to do it.”