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

NCT05343546 | Unknown DMC

• 1 other identifier: PAIC2021133
• Study Type: interventional
• Target: 2,076
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

incomplete abortion; Misoprostol; Intrauterine contraceptives; First trimester; Post Abortion care

Outcome Measures

Primary Outcomes (2)

• Rate of Continuation of Intrauterine contraceptive use at six months following insertion in both groups evaluated by follow up.

  The percentage of women who will be still having their IUDs insitu from history and within seven days "Early insertion" or 2-4 weeks "Standard insertion" after medical management of first trimester incomplete abortions. An interviewer administered questionnaire will be used to collect the information and pelvic examination will confirm presence or absence of IUD at every visit. Ultrasound scan will be used in case of any disparity.

  6 months from insertion of the post abortion intrauterine contraception

• Rate of Expulsion of the IUD devices at six months following insertion in both groups evaluated by follow up

  The percentage of women who will have their IUDs expelled by 6 months out of the total population of women recruited into the study will be defined as "Expulsion rates" either within seven days "Early insertion" or 2-4 weeks "Standard insertion" after medical management of first trimester incomplete abortions. An interviewer administered questionnaire will be used to collect the information and pelvic examination will confirm presence or absence of IUD at every visit. Ultrasound scan will be used in case of any disparity.

  6 months from insertion of the post abortion intrauterine contraception

Secondary Outcomes (4)

• Pain at IUD insertion

  immediately after the IUD insertion procedure

• Ease of IUD insertion

  immediately after the procedure of insertion

• Discontinuation rates

  This will at 6 and 12 months after the IUD placement

• Pregnancy rates

  12 months after IUD insertion

Study Arms (2)

Group 1: Early insertion

ACTIVE COMPARATOR

Early insertion will refer to Group 1 where a post abortion intrauterine device will be placed within seven days of giving medical management of first trimester incomplete abortion

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

Group 2: Standard insertion

ACTIVE COMPARATOR

Standard insertion will refer to Group 2 where a post abortion intrauterine device will be inserted in the recommended 2-4 weeks after medical management of first trimester incomplete abortion

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

Interventions

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

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"

Group 1: Early insertion; Group 2: Standard insertion

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Only women being managed for first trimester incomplete abortion undertaking medical management with Misoprostol will be enrolled into the study.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women eligible for medical management of first trimester incomplete abortion,
• Staying within ten kilometres from the health facility,
• Opting for post abortion IUC with no intention of conceiving within one year,
• Able and willing to comply with the planned follow up.

You may not qualify if:

• Women with known allergies to copper or Levonorgestrel IUDs,
• Patients with unsafe or septic abortions,
• Confirmed cervical cancer or with suspicious Pap smear cytology results demanding more work up,
• Hemoglobin level below 9 g/dl,
• Active genital tract infections,
• Coagulopathies,
• Known uterine anomalies,
• Suspected ectopic pregnancies
• Women with mental health issues that make it hard for them to comprehend the study protocols will be offered the standard of care but will be excluded from the study.

Sponsors & Collaborators

• Makerere University: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Herbert Kayiga

Wakiso, Central Region, Uganda

Location

Related Publications (11)

• General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2014 Summer;81(3):14-8.

  PMID: 25951678 BACKGROUND

• Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004 Aug;57(8):785-94. doi: 10.1016/j.jclinepi.2003.12.013.

  PMID: 15485730 RESULT

• Shimoni N, Davis A, Ramos ME, Rosario L, Westhoff C. Timing of copper intrauterine device insertion after medical abortion: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):623-628. doi: 10.1097/AOG.0b013e31822ade67.

  PMID: 21860292 RESULT

• Bearak J, Popinchalk A, Ganatra B, Moller AB, Tuncalp O, Beavin C, Kwok L, Alkema L. Unintended pregnancy and abortion by income, region, and the legal status of abortion: estimates from a comprehensive model for 1990-2019. Lancet Glob Health. 2020 Sep;8(9):e1152-e1161. doi: 10.1016/S2214-109X(20)30315-6. Epub 2020 Jul 22.

  PMID: 32710833 RESULT

• Hubacher D, Mavranezouli I, McGinn E. Unintended pregnancy in sub-Saharan Africa: magnitude of the problem and potential role of contraceptive implants to alleviate it. Contraception. 2008 Jul;78(1):73-8. doi: 10.1016/j.contraception.2008.03.002. Epub 2008 May 14.

  PMID: 18555821 RESULT

• Blumenthal PD, Voedisch A, Gemzell-Danielsson K. Strategies to prevent unintended pregnancy: increasing use of long-acting reversible contraception. Hum Reprod Update. 2011 Jan-Feb;17(1):121-37. doi: 10.1093/humupd/dmq026. Epub 2010 Jul 15.

  PMID: 20634208 RESULT

• Sawaya GF, Grady D, Kerlikowske K, Grimes DA. Antibiotics at the time of induced abortion: the case for universal prophylaxis based on a meta-analysis. Obstet Gynecol. 1996 May;87(5 Pt 2):884-90.

  PMID: 8677129 RESULT

• Sivin I, Tatum HJ. Four years of experience with the TCu 380A intrauterine contraceptive device. Fertil Steril. 1981 Aug;36(2):159-63.

  PMID: 7262334 RESULT

• IUD insertion following spontaneous abortion: a clinical trial of the TCu 220C, Liuppes loop D, and copper 7. Stud Fam Plann. 1983 Apr;14(4):109-14.

  PMID: 6351363 RESULT

• Gemzell-Danielsson K, Kopp HK. Post abortion contraception. Womens Health (Lond). 2015 Nov;11(6):779-84. doi: 10.2217/whe.15.72. Epub 2015 Nov 30.

  PMID: 26619082 RESULT

• Solo J, Billings DL, Aloo-Obunga C, Ominde A, Makumi M. Creating linkages between incomplete abortion treatment and family planning services in Kenya. Stud Fam Plann. 1999 Mar;30(1):17-27. doi: 10.1111/j.1728-4465.1999.00017.x.

  PMID: 10216893 RESULT

MeSH Terms

Conditions

Abortion, Incomplete

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Herbert Kayiga, MD, MPH

  Makerere University College of Health Sciences

  PRINCIPAL INVESTIGATOR

• Kristina Gemzell-Danielsson, MD, PhD

  Karolinska Institutet and Karolinska University Hospital

  STUDY DIRECTOR

Central Study Contacts

Dr.Herbert Kayiga

CONTACT

+256777855063; hkayiga@gmail.com

Josaphat Byamugisha, PhD

CONTACT

+256772580330; jbyamugisha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Designated study nurses and doctors will be responsible for recruiting and examining study participants at the outpatient clinic. Eligible women who choose to participate in the study and who sign an informed consent form will be randomized into either: Group 1; early insertion (insertion within 1 week of PAC) or Group 2; standard insertion (follow-up and insertion at 2-4 weeks post abortion) Women will be free to decide between the Cu-IUD (Nova T, Bayer AG, Berlin, Germany) and the LNG-IUS (Mirena H, Bayer AG, Berlin, Germany).

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 25, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within one year of publishing our research findings
• Access Criteria: I'll share the URL links as soon as they are available

Locations

UG (1)