Ideal Timing of Intrauterine Contraception Insertion After Medical Management of First Trimester Incomplete Abortion

Summary

Background: Unintended pregnancies continue to cause a public health threat in Low and Middle Income countries yet with restrictive abortion laws. Over 40% of these unintended pregnancies end up as unsafe abortions leading to significant maternal morbidity and mortality. With ovulation occurring between 5-10 days after first trimester abortion, 47% of the women conceive shortly afterwards yet nearly 50% of the women never return for follow up.

This study seeks to investigate effectiveness of early insertion of Intrauterine contraception (IUC) (within one week after medical Post abortion care (mPAC)) compared to Standard IUC insertion (between 2-4 weeks post PAC), in Uganda with the ultimate aim of increasing the uptake of IUC post 1st trimester medical management of incomplete abortion.

Hypothesis:

Null hypothesis: Early Insertion of IUC has higher expulsion rates and continued use than standard insertion after medical management among women with first trimester incomplete abortion at six months within a non-inferiority margin of 7.5%.

Alternate hypothesis: Early Insertion of IUC has similar expulsion rates and continued use as standard insertion after medical management among women with first trimester incomplete abortion at six months within a non-inferiority margin of 7.5%.

Methods: A Non-inferiority RCT of 2,076 participants will be conducted in 15 health facilities within Central Uganda. Baseline participant characteristics will be analyzed using descriptive statistics. For continuous variables, statistical tests such as Fisher's exact test, t-test, ANOVA and Wilcoxon-Mann-Whitney test will be used as appropriate. Binary logistic regression model will be used for factors associated with the dependent variable uptake of intrauterine contraception with p-value set \<0.05 as level of significance. Intention to treat and per protocol analysis will be used for the RCTs.

Study utility: A greater proportion of women undergoing medical post abortion care for incomplete abortion will receive their intended post abortion IUC within the first days after the PAC treatment compared with routine insertion at a scheduled follow up visit 2-4 weeks later. Though there could be higher expulsion rates in the early versus the standard IUC insertion, continued use at 6 months following abortion will be higher in the early insertion group as compared to the standard insertion group thereby reducing unplanned and unwanted pregnancy.

Conditions

• Incomplete Abortion
• Intrauterine Contraception
• Misoprostol

Interventions

DEVICE

Use of either copper T380A or Levonorgestrel LNG 52 IUS after medical management of first trimester incomplete abortion

Use of either copper T380A or Levonorgestrel LNG 52 IUS after medical management of first trimester incomplete abortion within seven days of giving Misoprostol "Early insertion" or 2-4 weeks after Misoprostol use "Standard insertion"

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Makerere University

  lead OTHER

Principal Investigators

• Herbert Kayiga, MD, MPH · Makerere University College of Health Sciences

• Kristina Gemzell-Danielsson, MD, PhD · Karolinska Institutet and Karolinska University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-30

Primary Completion

2024-06-30

Completion

2025-06-30

Countries

• Uganda

Study Locations