A randomised clinical trial to assess satisfaction with the levonorgestrel- releasing intrauterine system inserted at caesarean section compared to postpartum placement.
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ABSTRACT: Background
Insertion of levonorgestrel-releasing intrauterine system (LNG-IUS) at caesarean section (CS) provides contraception prior to resumption of ovulation or sexual activity. Patient satisfaction with insertion at CS has not previously been studied.Aims
The aim of this study was to compare patient satisfaction with LNG-IUS inserted at the time of lower uterine segment CS to six weeks postpartum.Materials and methods
Open-label randomised controlled trial. Women booked for elective CS were randomised to LNG-IUS insertion either at the time of CS (study group) or at six weeks postpartum (control group). The primary outcome measure was patient satisfaction. Outcomes were measured at six weeks, three months and six months postpartum.Results
Forty-eight women were randomised into two treatment groups. Twenty-five women were randomised to have LNG-IUS inserted at the time of CS, 23 of whom had the planned intervention and two had the LNG-IUS inserted postpartum. Twenty-three women were randomised to the control group, four of whom withdrew prior to treatment. The 44 remaining women contributed to data analysis. Patient satisfaction was high and similar in both groups. At six months postpartum, 90.5% of the study group were very satisfied or somewhat satisfied compared with 88.2% of the control group.Conclusions
Patient satisfaction is high with LNG-IUS insertion at CS and not different to that with delayed insertion. LNG-IUS insertion may be an option for women who find postpartum contraception difficult to access.
SUBMITTER: Braniff K
PROVIDER: S-EPMC5032983 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC8200645 | biostudies-literature
Project description:BackgroundThe objective of this study was to determine the feasibility of postpartum levonorgestrel intrauterine system (LNG-IUS) placement on the postpartum ward.Study designThis case-series study took place in a teaching hospital in North Carolina. Women were followed for 6 months, and data on method satisfaction, study design satisfaction and expulsion were collected. Descriptive statistics were used.ResultsForty women enrolled. Twenty-nine women (73%) received the LNG-IUS at a median of 20 h (range 7-48 h) after delivery, and all reported that they would recommend this method of contraception to a friend. Eleven women had a spontaneous expulsion (38%; 95% confidence interval 21, 58).ConclusionPlacement of LNG-IUS more than 6 h postpartum was acceptable to women in this study. The expulsion rate of 38% had statistical instability and should be interpreted with caution. However, our report may assist with individual counseling of women interested in postpartum LNG-IUS placement, or in future study designs.
| S-EPMC3277642 | biostudies-literature
Project description:Study questionWhat is the bleeding pattern during second consecutive levonorgestrel-releasing intrauterine system (LNG-IUS) use?Summary answerConsecutive use of LNG-IUS is associated with a predictable bleeding pattern, characterized by the absence of the initial period of irregular bleeding seen after interval insertion of an LNG-IUS and a non-bleeding pattern in the vast majority of women.What is known alreadyWith increased popularity of the LNG-IUS for long-term birth control and treatment of heavy menstrual bleeding (HMB), consecutive use of the system is becoming more frequent. One previous study showed 60% amenorrhea rate in consecutive IUS users; however, the sample size was small.Study design, size, durationA prospective multicenter study in four European countries recruited women who wished to continue with LNG-IUS use immediately after the first 5-year period. A total of 204 women were followed up until the end of the first year of the second IUS. Thereafter 170 women continued into the extension phase of the study up to the full 5 years of use of the second IUS and 144 women continued to the end of the study.Participants, setting, methodsA total of 170 women (mean age 39 years) who had been using their first LNG-IUS for between 4 years 3 months and 4 years 9 months, either for contraception or for treatment of HMB, and who planned to replace the device with a new LNG-IUS, were recruited and followed up to 5 years of the second IUS use. A total of 17 centers in four European countries were involved in the study. Bleeding patterns were analyzed using daily bleeding diaries using 90-day reference periods (RP) for the first year of the second IUS use and for the last RP of each year during Years 2-5 of use.Main results and the role of chanceApproximately 70% of women were free of bleeding during Years 2-5 and up to 49% were amenorrheic. There was a slight increase in the number of bleeding/spotting days of ∼3 days during the first RP immediately after the placement of the second IUS, whereafter the number of bleeding/spotting days returned to the level preceding the second IUS insertion or below that. Absence of bleeding was associated with high overall satisfaction and continuation rates. No serious adverse events assessed as related to the LNG-IUS use occurred during the 5-year period. The cumulative expulsion rate during the 5-year study period was 1.2%. The sample size was large enough to study bleeding patterns, and subjects are likely to represent typical consecutive IUS users, and therefore, the role of chance is small.Limitations, reasons for cautionThe women represent a selected group as they had already successfully used their first IUS for almost 5 years and were willing to continue its use-however, this is currently a common clinical situation. The results may therefore not be extrapolated to first-time users of the LNG-IUS.Wider implications of the findingsThese data are of importance when counseling women who are making decisions concerning long-term contraception.Study funding/competing interest(s)This study was funded by Bayer Pharma AG. P.I. and T.S. are full-time employees of Bayer Pharma AG. O.H. and K. G-D. have received consultancy fees from Bayer Pharma AG. The publication was developed jointly by all authors without third-party involvement and no honoraria were paid for any authors for their contribution to this manuscript.Trial registration numberNCT00393198.
| S-EPMC4017944 | biostudies-literature
Project description:BackgroundBreastfeeding and postpartum contraception critically influence infant and maternal health outcomes. In this pilot study, we explore the effects of timing and duration of postpartum levonorgestrel exposure on milk lipid and levonorgestrel content to establish baseline data for future research.MethodsThis sub-study recruited a balanced convenience sample from 259 participants enrolled in a parent randomized controlled trial comparing immediate to delayed (4-8 weeks) postpartum levonorgestrel IUD placement. All planned to breastfeed, self-selected for sub-study participation, and provided the first sample at 4-8 weeks postpartum (before IUD placement for the delayed group) and the second four weeks later. We used the Wilcoxon rank sum (inter-group) and signed rank (intra-group) tests to compare milk lipid content (creamatocrit) and levonorgestrel levels between groups and time points.ResultsWe recruited 15 participants from the immediate group and 17 from the delayed group with 10 and 12, respectively, providing both early and late samples. Initially, median levonorgestrel concentration of the immediate group (n?=?10) (32.5 pg/mL, IQR: 24.8, 59.4) exceeded that of the delayed group (n?=?12) (17.5 pg/mL, IQR: 0.0, 25.8) (p?=?0.01). Four weeks later, the values aligned: 26.2 pg/mL (IQR: 20.3, 37.3) vs. 28.0 pg/mL (IQR: 25.2, 40.8). Creamatocrits were similar between both groups and timepoints.ConclusionsImmediate postpartum levonorgestrel IUD placement results in steady, low levels of levonorgestrel in milk without apparent effects on lipid content. These findings provide initial support for the safety of immediate postpartum levonorgestrel IUD initiation, though the study was not powered to detect noninferiority between groups.Trial registrationThis randomized controlled trial was registered with ClinicalTrials.gov (Registry No. NCT01990703) on November 21, 2013.
| S-EPMC7818753 | biostudies-literature
Project description:ObjectivesWe describe the first application of intrauterine negative-pressure therapy (IU-NPT) for an early rupture of a uterine suture after a third caesarean section with consecutive peritonitis and sepsis. Because all four quadrants were affected by peritonitis, a laparotomy was performed on the 15th day after caesarean section. Abdominal negative-pressure wound therapy (A-NPWT) of the open abdomen was initiated. During the planned relaparotomy, a suture defect of the anterior uterine wall was identified and sutured. In the second relaparotomy, the suture appeared once more insufficient.Case presentationFor subsequent IU-NPT, we used an open-pore film drainage (OFD) consisting of a drainage tube wrapped in the double-layered film. The OFD was inserted into the uterine cavity via the uterine defect and IU-NPT was established together with A-NPT. With the next relaparotomy, local inflammation and peritonitis had been resolved completely. IU-NPT was continued transvaginally, the uterine defect was sutured, and the abdomen was closed. Vaginal IU-NPT was also discontinued after another eight days.ConclusionsBy using IU-NPT, local infection control of the septic focus was achieved. The infectious uterine secretions were completely evacuated and no longer discharged into the abdominal cavity. As a result of the applied suction, the uterine cavity collapsed around the inlaid OFD. The total duration of IU-NPT was 11 days. The uterine defect was completely closed, and a hysterectomy was avoided. The patient was discharged four days after the end of IU-NPT. IU-NPT follows the same principles as those described for endoscopic negative-pressure wound therapy of the gastrointestinal tract.
| S-EPMC7798308 | biostudies-literature
Project description:The aim of this review was to summarize the available evidence about the use of levonorgestrel-releasing intrauterine system (LNG-IUS) as a contraceptive method in nulliparous women. For this purpose, studies evaluating the efficacy, safety, bleeding pattern, satisfaction and discontinuation of the levonorgestrel-releasing intrauterine system in nulliparous women were analyzed. Only original research articles published in English between 1990-27th March 2020 were considered eligible. Reviews, book chapters, case studies, conference papers, opinions, editorials and letters were excluded. The systematic literature search of PubMed/MEDLINE, Scopus, Embase and Cochrane Library databases identified 816 articles, 23 of which were analyzed. The available evidence indicates that LNG-IUS is an effective and safe contraceptive method for nulliparous women that achieves high levels of satisfaction among patients. Moreover, nulliparous women seem to experience fewer expulsions than parous ones. Bleeding pattern is acceptable for the majority of patients, and bleeding disorders mainly occur in the first months after the insertion. More in-depth, long-term prospective studies are needed in this patient group to determine risk factors for the occurrence of side effects and associated discontinuations, which should not, however, delay the wider use of the method in this group, given the number of advantages.
| S-EPMC7408997 | biostudies-literature
Project description:ObjectiveTo simulate hysteroscopic suturing in vitro and analyze the learning curve of gynecologists with different experience levels.MethodsThree gynecologists were trained on uterine models in a circulating water box. The posterior uterine wall was sutured 10 times under hysteroscopy for 5 consecutive days, and the time of each suture procedure was recorded.ResultsDoctors A, B, and C completed 50 posterior uterine sutures. After Dr. C completed 50 sutures on the posterior wall, he added 50 sutures on the anterior wall (Group D). The mean suturing time was 71.54 ± 68.158 s in Group A, 50.10 ± 28.060 s in Group B, 34.04 ± 10.457 s in Group C, and 30.38 ± 8.734 s in Group D. The difference between Groups C and B and between Groups B and A was statistically significant. There was no statistically significant difference between Groups C and D. Simulation curves were created using the number of features as the abscissa and cumulative sum as the coordinate, with peak curves of 19, 27, and 18 cases for Group A, B, and C, respectively.ConclusionDoctors with experience in single-hole laparoscopic surgery or hysteroscopic suture surgery can significantly shorten the hysteroscopic suturing time.
| S-EPMC10590047 | biostudies-literature
Project description:ImportanceThe early postpartum period, 2 to 4 weeks after birth, may be a convenient time for intrauterine device (IUD) placement; the placement could then coincide with early postpartum or well-baby visits.ObjectiveTo determine expulsion rates for IUDs placed early postpartum compared with those placed at the standard interval 6-week visit.Design, setting, and participantsIn this randomized noninferiority trial, people who had a vaginal or cesarean birth were randomly assigned to undergo early (14-28 days) or interval (42-56 days) postpartum IUD placement. Clinicians blinded to participant study group used transvaginal ultrasonography to confirm IUD presence and position at the 6-month postpartum follow-up. The study assessed 642 postpartum people from 4 US medical centers, enrolled a consecutive sample of 404 participants from March 2018 to July 2021, and followed up each participant for 6 months postpartum.InterventionsEarly postpartum IUD placement, at 2 to 4 weeks postpartum, vs standard interval placement 6 to 8 weeks postpartum.Main outcomes and measuresThe primary outcome was complete IUD expulsion by 6 months postpartum; the prespecified noninferiority margin was 6%. Secondary outcomes were partial IUD expulsion, IUD removal, pelvic infection, patient satisfaction, uterine perforation, pregnancy, and IUD use at 6 months postpartum. IUD malposition was an exploratory outcome.ResultsAmong 404 enrolled participants, 203 participants were randomly assigned to undergo early IUD placement and 201 to undergo interval IUD placement (mean [SD] age, 29.9 [5.4] years; 46 [11.4%] were Black, 228 [56.4%] were White, and 175 [43.3%] were Hispanic). By 6 months postpartum, 53 participants (13%) never had an IUD placed and 57 (14%) were lost to follow-up. Among the 294 participants (73%) who received an IUD and completed 6-month follow-up, complete expulsion rates were 3 of 149 (2.0% [95% CI, 0.4%-5.8%]) in the early placement group and 0 of 145 (0% [95% CI, 0.0%-2.5%]) in the interval placement group (between-group difference, 2.0 [95% CI, -0.5 to 5.7] percentage points). Partial expulsion occurred in 14 (9.4% [95% CI, 5.2%-15.3%]) participants in the early placement group and 11 (7.6% [95% CI, 3.9%-13.2%]) participants in the interval placement group (between-group difference, 1.8 [95% CI, -4.8 to 8.6] percentage points). IUD use at 6 months was similar between the groups: 141 (69.5% [95% CI, 62.6%-75.7%]) participants in the early group vs 139 (67.2% [95% CI, 60.2%-73.6%]) in the interval group.Conclusions and relevanceEarly IUD placement at 2 to 4 weeks postpartum compared with 6 to 8 weeks postpartum was noninferior for complete expulsion, but not partial expulsion. Understanding the risk of expulsion at these time points may help patients and clinicians make informed choices about the timing of IUD placement.Trial registrationClinicalTrials.gov Identifier: NCT03462758.
| S-EPMC10031390 | biostudies-literature
Project description:BackgroundHeavy menstrual bleeding affects as many as one in three women and has negative physical, economic, and psychosocial impacts including activity limitations and reduced quality of life. The goal of treatment is to make menstruation manageable, and options include medical therapy or surgery such as endometrial ablation or hysterectomy. This review examined the evidence of effectiveness and cost-effectiveness of the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) as a treatment alternative for idiopathic heavy menstrual bleeding.MethodsWe conducted a systematic review of the clinical and economic evidence comparing LNG-IUS with usual medical therapy, endometrial ablation, or hysterectomy. Medline, EMBASE, Cochrane, and the Centres for Reviews and Dissemination were searched from inception to August 2015. The quality of the evidence was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also completed an economic evaluation to determine the cost-effectiveness and budget impact of the LNG-IUS compared with endometrial ablation and with hysterectomy. The economic evaluation was conducted from the perspective the Ontario Ministry of Health and Long-Term Care.ResultsRelevant systematic reviews (n = 18) returned from the literature search were used to identify eligible randomized controlled trials, and 16 trials were included. The LNG-IUS improved quality of life and reduced menstrual blood loss better than usual medical therapy. There was no evidence of a significant difference in these outcomes compared with the improvements offered by endometrial ablation or hysterectomy. Mild hormonal side effects were the most commonly reported. The quality of the evidence varied from very low to moderate across outcomes. Results from the economic evaluation showed the LNG-IUS was less costly (incremental saving of $372 per person) and more effective providing higher quality-adjusted life years (incremental value of 0.05) compared with endometrial ablation. Similarly, the LNG-IUS costs less (incremental saving of $3,138 per person) and yields higher quality-adjusted life-years (incremental value of 0.04) compared with hysterectomy. Publicly funding LNG-IUS as an alternative to endometrial ablation and hysterectomy would result in annual cost savings of $3 million to $9 million and $0.1 million to $23 million, respectively, over the first 5 years.ConclusionsThe 52-mg LNG-IUS is an effective and cost-effective treatment option for idiopathic heavy menstrual bleeding. It improves quality of life and menstrual blood loss, and is well tolerated compared with endometrial ablation, hysterectomy, or usual medical therapies.
| S-EPMC5159479 | biostudies-literature
Project description:BackgroundThe levonorgestrel-releasing intrauterine system (LNG-IUS) is widely used in contraception, menorrhagia, dysmenorrhea and to prevent endometrial hyperplasia during estrogen supplementation. Perforation is more often seen after early postpartum placement. Perforation of the LNG-IUS occurring one month after placement is rare.Case summaryA 42-year-old female complained of progressive dysmenorrhea and increased menstrual volume. She was diagnosed with adenomyosis and the LNG-IUS was inserted in her uterine cavity. Routine ultrasound examination one month later revealed that the intra-uterine device (IUD) was not found in the uterine cavity, and further X-ray and pelvic magnetic resonance imaging showed an abnormal signal area in the left posterior region of the uterus. Laparoscopic exploratory surgery was performed and the LNG-IUS was found in the left uterosacral ligament.ConclusionPerforation of a LNG-IUS occurring one month after placement is rare, and is more common in inexperienced operators and after early postpartum placement. When the operation is difficult, ultrasound monitoring is recommended to reduce the risk of IUD perforation. For patients with inadequate surgery, postoperative imaging is recommended to detect potential risks as soon as possible.
| S-EPMC9846966 | biostudies-literature