Instruction-only versus demonstration of a low sensitivity pregnancy test for self-assessment of medical abortion in South Africa; a multicenter non-inferiority randomized controlled trial.
ESC Congress Library. CONSTANT D. 05/04/16; 126829; A-002 Disclosure(s): Disclosure on the poster
Ms. Deborah CONSTANT
Ms. Deborah CONSTANT
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Abstract
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Objectives: To compare instruction-only to demonstration of a low-sensitivity pregnancy test for self-assessment of abortion outcome.

Methods: This non-inferiority randomized controlled trial was conducted in 6 public sector abortion clinics in South Africa. Eligible women were 18 years and older, with a confirmed intra-uterine pregnancy up to 63 days’ gestation, clinically eligible for medical abortion, fluent in English or isiXhosa, have a working cellphone with them at enrollment, and be willing to receive abortion-related text messages on their phone. Consenting women received standard care with mifepristone and home administration of misoprostol. All were sent automated reminders and support text messages over 14 days following enrollment, given a low–sensitivity pregnancy test and checklist, and asked to attend in-clinic follow-up two weeks later.

Computer generated randomization with block sizes (8-20) assigned participants in a 1:1 ratio to study groups. The instruction-only group were issued with a pre-scripted  set of test instructions, the demonstration group practiced the low-sensitivity pregnancy test on their urine sample in the clinic, guided by fieldworkers using the same set of instructions. All women were asked to attend in-clinic follow-up two weeks later. Primary outcome was accurate home self-assessment of the need or not for surgical or medical treatment to complete the abortion. Secondary outcomes included ease of doing the test and preference for follow-up method. Analysis was by intention to treat and the non-inferiority margin was set at six percentage points.

Results: Of the 525 enrolled, 252 were assigned to instruction-only and 263 to demonstration. At follow-up 208 and 218 had primary outcomes, and 227 and 231 had secondary outcomes in the instruction-only and demonstration groups, respectively.

In-clinic follow-up showed complete abortion with no additional treatment (MVA or additional misoprostol) for 91% (190/208; 199/218) in both groups. Accuracy of self-assessment was 85% (177/208) for the instruction-only and 88% (191/218) for demonstration group. Of the 3 ongoing pregnancies in the study, 1 from the demonstration group reported a negative pregnancy test. 99% (224/227) and 99.6% (230/231) found the pregnancy test easy to do, and 91% (207/227) and 93% (214/231) preferred the combination of pregnancy test, checklist and text messages for abortion assessment.

Conclusion: Instruction-only is not inferior to a pregnancy test demonstration for accurate assessment of the need or not for additional treatment following medical abortion. However, introduction of routine self-assessment, though preferred by women, requires counselling to ensure ongoing pregnancies are not missed and complications are recognized.

 

Objectives: To compare instruction-only to demonstration of a low-sensitivity pregnancy test for self-assessment of abortion outcome.

Methods: This non-inferiority randomized controlled trial was conducted in 6 public sector abortion clinics in South Africa. Eligible women were 18 years and older, with a confirmed intra-uterine pregnancy up to 63 days’ gestation, clinically eligible for medical abortion, fluent in English or isiXhosa, have a working cellphone with them at enrollment, and be willing to receive abortion-related text messages on their phone. Consenting women received standard care with mifepristone and home administration of misoprostol. All were sent automated reminders and support text messages over 14 days following enrollment, given a low–sensitivity pregnancy test and checklist, and asked to attend in-clinic follow-up two weeks later.

Computer generated randomization with block sizes (8-20) assigned participants in a 1:1 ratio to study groups. The instruction-only group were issued with a pre-scripted  set of test instructions, the demonstration group practiced the low-sensitivity pregnancy test on their urine sample in the clinic, guided by fieldworkers using the same set of instructions. All women were asked to attend in-clinic follow-up two weeks later. Primary outcome was accurate home self-assessment of the need or not for surgical or medical treatment to complete the abortion. Secondary outcomes included ease of doing the test and preference for follow-up method. Analysis was by intention to treat and the non-inferiority margin was set at six percentage points.

Results: Of the 525 enrolled, 252 were assigned to instruction-only and 263 to demonstration. At follow-up 208 and 218 had primary outcomes, and 227 and 231 had secondary outcomes in the instruction-only and demonstration groups, respectively.

In-clinic follow-up showed complete abortion with no additional treatment (MVA or additional misoprostol) for 91% (190/208; 199/218) in both groups. Accuracy of self-assessment was 85% (177/208) for the instruction-only and 88% (191/218) for demonstration group. Of the 3 ongoing pregnancies in the study, 1 from the demonstration group reported a negative pregnancy test. 99% (224/227) and 99.6% (230/231) found the pregnancy test easy to do, and 91% (207/227) and 93% (214/231) preferred the combination of pregnancy test, checklist and text messages for abortion assessment.

Conclusion: Instruction-only is not inferior to a pregnancy test demonstration for accurate assessment of the need or not for additional treatment following medical abortion. However, introduction of routine self-assessment, though preferred by women, requires counselling to ensure ongoing pregnancies are not missed and complications are recognized.

 

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