FDA ducks decision on emergency contraceptive.
Ontology highlight
ABSTRACT:
SUBMITTER: Tanne JH
PROVIDER: S-EPMC1215548 | biostudies-literature | 2005 Sep
REPOSITORIES: biostudies-literature
Publications
FDA ducks decision on emergency contraceptive.
BMJ (Clinical research ed.) 20050901 7517
Similar Datasets
Project description:ObjectivesTo prospectively evaluate (1) pregnancy desirability, (2) stated intentions should pregnancy occur among emergency contraception (EC) users, and (3) explore differences between women selecting the copper T380 intrauterine device (Cu IUD) or oral levonorgestrel (LNG) regarding hypothetical pregnancy plans and actual pregnancy actions during subsequent unintended pregnancies.Study designIn this prospective observational trial, women received the Cu IUD or oral LNG for EC without cost barriers. At baseline, participants completed a visual analogue scale measuring pregnancy desirability (anchors: 0, "trying hard not to get pregnant"; 10, "trying hard to get pregnant") and self-reported plans (abortion, adoption, parenting, and unsure) if the pregnancy test were to come back positive. Pregnancies were tracked for 12 months, and actions regarding unintended pregnancies were compared between EC method groups.ResultsOf 548 enrolled women, 218 chose the Cu IUD and 330 the oral LNG for EC. Pregnancy desirability at baseline was low, with no difference between EC groups (IUD group: 0.51, SD ± 1.60; LNG group: 0.68, SD ± 1.74). Fifty-four (10%) women experienced unintended pregnancies. Pregnancy plans from baseline changed for 27 (50%) women when they became pregnant. EC groups did not differ in hypothetical pregnancy intention (p = 0.15) or in agreement of hypothetical pregnancy intention with actual pregnancy action (p = 0.80).ConclusionsWomen presenting for EC state high desire to prevent pregnancy regardless of method selected. When considering a hypothetical pregnancy, half of women had a plan for how they would respond to that situation, but when confronting an actual unintended pregnancy, half altered their plan.Clinical trial registration numberClinicaltrials.gov identifier NCT00966771.
| S-EPMC5069714 | biostudies-literature
Project description: Not available
| S-EPMC1255820 | biostudies-literature
Project description:Development of an effective male contraceptive agent remains a challenge. The present study evaluates the potential of N, N-Dimethylacetamide (DMA), a FDA approved excipient as a male contraceptive agent. Male Sprague Dawley rats injected with DMA for a period of 8 weeks (one injection per week) showed a significant alteration of reproductive parameters. Furthermore, DMA treated animals showed complete infertility in a dose dependent manner, as no pups were born despite proper mating between females and DMA treated males. However, stopping the DMA treatment for a period of 8 weeks (after the initial treatment) restored the reproductive parameters to normal. Moreover, the fertility was resumed to normal as pups were born in the groups where DMA treatment was halted after initial DMA treatment. All these changes had no effect on the level of reproductive hormones FSH, LH and testosterone. Taken together, our results indicate that DMA acts in a reversible and non-hormonal manner to achieve contraception in rats. Therefore, repurposing the use of DMA could lead in a short time to an inexpensive and safer male contraceptive option.
| S-EPMC7683412 | biostudies-literature
Project description:Women's contraceptive decision-making control is crucial for reproductive autonomy, but research largely relies on the Demographic and Health Survey (DHS) measure which asks who is involved with decision-making. In India, this typically assesses joint decision-making or male engagement. Newer measures emphasize female agency. We examined three measures of contraceptive decision-making, the DHS and two agency-focused measures, to assess their associations with marital contraceptive communication and use in rural Maharashtra, India. We analyzed follow-up survey data from women participating in the CHARM2 study (n = 1088), collected in June-December 2020. The survey included the DHS (measure 1), Reproductive Decision-Making Agency (measure 2), and Contraceptive Final Decision-Maker measures (measure 3). Only Measure 1 was significantly associated with contraceptive communication (adjusted odds ratio [AOR]: 2.75, 95 percent confidence interval [CI]: 1.69-4.49) and use (AOR: 1.73, 95 percent CI: 1.14-2.63). However, each measure was associated with different types of contraceptive use: Measure 1 with condom (adjusted relative risk ratio [aRRR]: 1.99, 95 percent CI: 1.12-3.51) and intrauterine device (IUD) (aRRR: 4.76, 95 percent CI: 1.80-12.59), Measure 2 with IUD (aRRR: 1.64, 95 percent CI: 1.04-2.60), and Measure 3 with pill (aRRR: 2.00, 95 percent CI: 1.14-3.52). Among married women in Maharashtra, India, male engagement in decision-making may be a stronger predictor of contraceptive communication and use than women's agency, but agency may be predictive of types of contraceptives used.
| S-EPMC10695302 | biostudies-literature
Project description: Not available
| S-EPMC1289348 | biostudies-literature
Project description: Not available
| S-EPMC11220612 | biostudies-literature
Project description:Estimated use of emergency contraception (EC) remains low, and one reason is measurement challenges. The study aims to compare EC use estimates using five approaches. Data come from Performance Monitoring and Accountability 2020 surveys from 10 countries, representative sample surveys of women aged 15 to 49 years. We explore EC use employing the five definitions and calculate absolute differences between a reference definition (percentage of women currently using EC as the most effective method) and each of the subsequent four, including the most inclusive (percentage of women having used EC in the past year). Across the 17 geographies, estimated use varies greatly by definition and EC use employing the most inclusive definition is statistically significantly higher than the reference estimate. Impact of using various definitions is most pronounced among unmarried sexually active women. The conventional definition of EC use likely underestimates the magnitude of EC use, which has unique programmatic implications.
| S-EPMC7187174 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness of a contraceptive decision aid in reducing decisional conflict among women seeking reversible contraception.Study designWe conducted a randomized trial of a computer-based decision aid compared to a control group for women presenting for reversible contraception at two clinics affiliated with an academic medical center. The primary outcome was change in decisional conflict, measured before and after the healthcare visit using the validated Decisional Conflict Scale. We hypothesized the decision aid would reduce the decisional conflict score by 10 points on a 100-point scale (0 = no conflict, 100 = high conflict) compared to the control group. Secondary outcomes included contraceptive method chosen and satisfaction with the healthcare visit.ResultsWe enrolled and randomized 253 women, and 241 had complete data for our primary outcome. Overall, pre-visit decisional conflict scores were low, reflecting low levels of decisional conflict in our sample; median score 15 (range 0-80) in the decision aid and 10 (0-85) in the control group (p = 0.45). Both groups had a similar reduction in median decisional conflict after the healthcare visit: -10 (-80 to 25) and -10 (-60 to 5) in the decision aid and control groups respectively (p = 0.99). Choice of contraception (p = 0.23) and satisfaction with healthcare provider (p = 0.79) also did not differ by study group.ConclusionsDecisional conflict around contraception was low in both groups at baseline. Use of a computerized contraceptive decision aid did not reduce decisional conflict, alter method choice, or impact satisfaction compared to the control group among women choosing reversible contraception.ImplicationsUse of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception. Future studies could focus on testing the decision aid in different clinical settings, especially where barriers to providing comprehensive contraceptive counseling exist.
| S-EPMC7821473 | biostudies-literature
Project description: Not available
| S-EPMC10035172 | biostudies-literature
Project description:PurposeTo evaluate the feasibility and acceptability of a text messaging intervention to increase contraception among adolescent emergency department patients.MethodsA pilot randomized controlled trial of sexually active females aged 14-19 receiving 3 months of theory-based, unidirectional educational and motivational texts providing reproductive health information versus standardized discharge instructions. Blinded assessors measured contraception initiation via telephone follow-up and health record review at 3 months.ResultsWe randomized 100 eligible participants (predominantly aged 18-19, Hispanic, and with a primary provider); 88.0% had follow-up. In the intervention arm, 3/50 (6.0%) participants opted out, and 1,172/1,654 (70.9%) texts were successfully delivered; over 90% of message failures were from one mobile carrier. Most (36/41; 87.7%) in the intervention group liked and wanted future reproductive health messages. Contraception was initiated in 6/50 (12.0%) in the intervention arm and in 11/49 (22.4%) in the control arm.ConclusionsA pregnancy prevention texting intervention was feasible and acceptable among adolescent females in the emergency department setting.
| S-EPMC5701840 | biostudies-literature