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Showing 1-16 of 16 trials
NCT07138248
This study aims to evaluate the position of intrauterine devices (IUDs) six weeks after insertion using transvaginal three-dimensional (3D) ultrasound. Women aged 18-45 who undergo postpartum IUD insertion, either vaginally or during cesarean delivery, will be included. The study will compare the accuracy of 3D ultrasound versus conventional two-dimensional (2D) ultrasound in detecting IUD displacement, including partial expulsion, embedment, or perforation. Participants will receive a copper T380A IUD, and all procedures will follow standard clinical protocols. Ultrasound assessments will be conducted six weeks after insertion to confirm proper placement. Data collected will include demographic information, reproductive history, and ultrasound findings. The primary outcome is the prevalence of IUD displacement at six weeks. Secondary outcomes include the diagnostic accuracy of 3D versus 2D ultrasound. This study is designed to improve early detection of malpositioned IUDs, enhancing patient safety and contraceptive effectiveness.
NCT06891794
This prospective, open label, double arm, feasibility group study will recruit participants planning to undergo office intrauterine device (IUD) placement without sedation or anxiolysis at the Center for Women's Health. Participants will self-administer a topical anesthetic using a contraceptive cervical cap or menstrual disc. Twenty-four nulliparous women will be recruited to receive one of two administration methods immediately prior to IUD placement (12 subjects in each arm): 1) menstrual disc filled with 5g eutectic mixture of local anesthetics (EMLA) cream or 2) cervical cap filled with 5g EMLA cream.
NCT06240260
Subjects will be screened over the phone or in Tufts GYN clinic for participation in the study. If eligible and interested in participating, written informed consent (and assent if applicable) will be obtained. After informed consent/assent, the patient will be enrolled in the study. The patient will decide if they desire to use TENS unit during IUD insertion appointment and inform the study team. The clinic visit will proceed as normal, with additional study proceedings as follows. The study personnel will complete the 'Background Questionnaire' with the patient prior to IUD insertion. During the IUD insertion appointment, study personnel will assist in collection of the 'Study visit' data collection form. This includes recording the patient's pain score at various time points throughout the insertion procedure: * anticipated pain during IUD insertion * baseline pain prior to insertion * speculum insertion * tenaculum placement * paracervical block administration (if performed) * cervical dilation (if performed) * uterine sounding * IUD insertion * 5 minutes after IUD insertion Study personnel will also time the insertion procedure and collect additional data as outlined in the 'Study visit data collection form.' After IUD insertion, the participant will be asked to complete the 'Post-IUD Insertion Survey.' Once this survey is complete, this will conclude the study participation. Participation will last through the study visit only. As part of the standard of care, a urine pregnancy test will be obtained and confirmed negative prior to IUD insertion. Patients will receive routine pain management modalities per shared decision-making with their clinical provider which may include NSAID administration, paracervical block, and heating pad.
NCT05875571
Intrauterine devices (IUDs) are a popular form of long-acting reversible contraception, with a high efficacy rate and few side effects. The insertion procedure for IUDs can be uncomfortable and painful. Sedation may be needed to improve patient comfort. The use of IUDs is increasing in the adolescent population, but perceived pain is a barrier to placement. Propofol is a commonly used agent for pediatric procedural sedation, but it has no analgesic properties. Ketorolac, a nonsteroidal anti-inflammatory drug, has been shown to reduce pain in adults and improve patient satisfaction when used prior to IUD placement.. The current study aims to determine if ketorolac, given in combination with propofol for IUD placement in adolescents, can improve comfort during placement and reduce pain following the procedure. Enrolled patients will receive ketorolac or placebo, in addition to propofol, for IUD placement. By comparing the outcomes of these two groups of patients, we can gain a better understanding of the optimal approach to sedation for IUD insertion in adolescents.
NCT05594108
The objective of this pilot study is to test that hypothesis that ultrasound guided IUD placement by family medicine residents improves patient pain scores, procedure completion time, and procedure complication rates. The secondary objective is to test the hypothesis that ultrasound guided IUD placement improves resident confidence in performing the procedure. A prospective, randomized controlled pilot study will be conducted in the Department of Academic Family Medicine at the University of Saskatchewan. All women undergoing IUD placement (hormonal or non-hormonal) at West Winds Primary Care Center from Mar 1, 2020- Mar 1, 2021 will be invited to participate. Informed consent will be obtained from each patient and the resident inserting the IUD prior to initiating study procedures. The control group will comprise 20 women undergoing non-ultrasound guided IUD placement. The experimental group will comprise 20 women undergoing transabdominal ultrasound guided IUD placement. Patient pain scores and resident confidence scores will be tabulated using likert scales and compared between control and experimental groups using independent sample t-tests. Procedure completion time (minutes) will be compared between groups using t-tests. Procedure complications rates will be categorized as: a) inability to penetrate the cervix, b) improper location, c) inability to release the IUD from the insertion device, d) perforation, e) vasovagal reactions, and f) post-procedure infection; outcomes will be compared between groups using Chi-square analyses.
NCT05383924
After ethical committee approval and written consent from the patients, this prospective quasi-randomized controlled clinical trial was performed on pregnant women planning to deliver by cesarean section and willing to participate in the study to investigate the value of immediate post placental IUD insertion versus delayed insertion on patient's compliance in Ain Shams University Maternity Hospital (ASUMH).
NCT03828760
Although intrauterine devices (IUDs) are a highly effective contraceptive method, fear of pain during insertion is one barrier to use. A review of literature reveals little investigation of interventions for anxiety management during the procedure. Furthermore, evidence of non-pharmacological interventions for both anxiety and pain management is limited. Music has been shown to be effective at reducing anxiety and pain in a variety of contexts, however to the investigators' knowledge, its effectiveness for anxiety and pain relief during the IUD insertion procedure has not been formally examined. This study will therefore examine the effectiveness of listening to music on anxiety and pain during IUD insertion.
NCT04718337
The assessment of efficacy and patient safety of immediate postpartum IUD insertion using a novel technique.
NCT04646161
This is a prospective randomized controlled study to determine the effect of prostaglandin intake before Mirena IUD insertion It was conducted at the Department of Obstetrics \& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University,
NCT04441333
Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD). Currently, the available instruments are traumatic tenacula, which could cause pain and bleeding and therefore represent an obstacle for certain patients to pursue their medical follow-up. AspivixTM is a new device, which enables atraumatic traction of the cervix while respecting its specific semi-circular anatomic shape through a system powered by a vacuum chamber. The aim of our pilot study is to assess the usability, safety and efficacy of the device. Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details regarding comparative study is registered separately.
NCT04474548
This study will enroll women planning to have an intrauterine device (IUD) placed for contraception immediately following a vaginal delivery. Women will be randomized to have this procedure done with or without ultrasound guidance. We intend to determine if the routine use of ultrasound to confirm device position reduces the rates of IUD expulsion.
NCT03868137
This study compares the effectiveness of decreasing pain at time of and day after intrauterine device (IUD) insertion when patients take three doses of Ibuprofen versus three doses of placebo.
NCT04379102
Patients who visited our family planning clinic and opted for IUD application for contraception purposes were also offered NT/TLA treatments simultaneously. 40 patients who matched the inclusion criteria and received IUDs and NT/TLA treatments were included in the study group and 41 patients who only received IUDs were included in the control group. All patients received copper IUDs and none of them were on additional hormonal treatment. Before the insertion of IUD, women in the therapy group received NT treatment with 6ml of 1% procaine injected transvaginal into the cervix at 5 and 7 o'clock localizations. Following IUD insertion, another 6ml of 1% procaine was injected into the Frankenhauser ganglia bilaterally. A final dose of 8ml of 1% procaine was injected into the abdominal trigger points and intracutaneously into the L4-S4 dermatomes as quaddles.
NCT03939663
Role of vaginal misoprostol prior to IUCD insertion in women who delivered only by elective caesarean section.
NCT03724708
the investigators are trying to determine if this method of intrauterine device (IUD) insertion "hang up technique" has less expulsion rates than 6 week insertion or immediate post-placental insertion.
NCT02141321
The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered before only by cesarean section.