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Intrauterine Contraception clinical trials

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NCT ID: NCT05343546 Not yet recruiting - Misoprostol Clinical Trials

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

PAIC
Start date: June 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01685164 Completed - Clinical trials for Intrauterine Contraception

The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women

Start date: January 2011
Phase: N/A
Study type: Observational

As intrauterine contraception is an increasingly popular form of contraception the objective of our study is to examine if uterine size or posture affects the insertion or use of intrauterine devices. Nulliparous women requesting either the levonorgestrel-releasing device (LNG-IUS) or a copper-IUD (NovaT) are recruited and followed for one year.

NCT ID: NCT01022645 Completed - Type 2 Diabetes Clinical Trials

Postpartum Glucose Tolerance With Levonorgesterel IUD Use in Women With Recent Gestational Diabetes

Start date: November 2009
Phase: Phase 4
Study type: Observational

The study is being done in order to gain information on the most suitable types of birth control in women who recently had gestational diabetes, or diabetes diagnosed during pregnancy. The intrauterine device (IUD) is a highly effective form of birth control. It is inserted into the uterus and prevents pregnancy for either 5 or 10 years, depending on the type of IUD (hormone-releasing or copper). The hormone-releasing IUD works for 5 years and releases a hormone called a progestin into the uterus. The copper IUD contains no hormones and works for 10 years. The IUD is an excellent form of birth control postpartum, but it is unknown if the hormone-releasing IUD will affect blood sugars and increase a woman's risk of becoming diabetic when she's not pregnant. The hypothesis is that the hormone-containing IUD will NOT increase blood sugars, so women who use the hormone-containing IUD will have similar blood sugars to those who use the copper IUD or have had their tubes tied (no hormones).