Dataset Information

Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial.

ABSTRACT: To evaluate the efficacy of a paracervical block to decrease pain during osmotic dilator insertion before second-trimester abortion.In this double-blind, randomized trial, 41 women undergoing Laminaria insertion before a second-trimester abortion received either a paracervical block with 18 mL 1% lidocaine and 2 mL sodium bicarbonate or a sham block. Women were between 14 and 23 6/7 weeks of gestation. The primary outcome was pain immediately after insertion of Laminaria. Women assessed their pain on a 100-mm visual analog scale. Secondary outcomes included assessment of pain at other times during the insertion procedure and overall satisfaction with pain control. To detect a 25-mm difference in pain immediately after Laminaria insertion, at an ? of 0.05 and 80% power, we aimed to enroll 20 patients in each arm.From May 2015 to December 2015, 20 women received a paracervical block and 21 received a sham block. Groups were similar in demographics, including parity, history of surgical abortion, and number of Laminaria placed. The paracervical block reduced pain after Laminaria insertion (median scores 13 mm [interquartile range 2-39] compared with 54 mm [interquartile range 27-61], P=.01, 95% CI -47.0 to -4.0). Women who received a paracervical block also reported higher satisfaction with overall pain control throughout the entire Laminaria insertion procedure (median scores 95 mm [interquartile range 78-100] compared with 70 mm [interquartile range 44-90], P=.05, 95% CI 0.0-37.0).Paracervical block is effective at reducing the pain of Laminaria insertion. Additionally, a paracervical block increases overall patient satisfaction with pain control during Laminaria placement.ClinicalTrials.gov, NCT02454296.

SUBMITTER: Soon R

PROVIDER: S-EPMC5529236 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial.

Soon Reni R Tschann Mary M Salcedo Jennifer J Stevens Katelyn K Ahn Hyeong Jun HJ Kaneshiro Bliss B

Obstetrics and gynecology 20170801 2

<h4>Objective</h4>To evaluate the efficacy of a paracervical block to decrease pain during osmotic dilator insertion before second-trimester abortion.<h4>Methods</h4>In this double-blind, randomized trial, 41 women undergoing Laminaria insertion before a second-trimester abortion received either a paracervical block with 18 mL 1% lidocaine and 2 mL sodium bicarbonate or a sham block. Women were between 14 and 23 6/7 weeks of gestation. The primary outcome was pain immediately after insertion of ...[more]

PMID: 28697113

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Project description:BackgroundThe availability of modern contraception including long-acting reversible contraceptives (LARC), is a fundamental component of postabortion care. Findings from a recent randomized controlled trial (RCT) in South Africa comparing immediate to delayed insertion of the copper intrauterine device (IUD) after medical abortion (MA) at 17-20 gestational weeks showed that immediate insertion resulted in higher IUD use at 6 weeks postabortion, but that expulsion rates were significantly higher than for delayed insertion. This study aims to explore barriers, facilitators, and context-specific factors relevant to the implementation of immediate IUD provision after second trimester medical abortion.MethodsWe performed a qualitative study alongside the RCT in which we conducted in-depth interviews with 14 staff providing healthcare to study participants and 24 study participants. Research questions explored barriers and facilitators to implementation of immediate IUD insertion, contraceptive decision-making, and the impact of context and supplementary trial activities on service provision. Interviews were recorded and transcribed, with translation into English if needed. We performed a triangulated thematic analysis at the level of the transcribed interview text.ResultsContraceptive counselling at the abortion facility by a study nurse improved knowledge, corrected misconceptions, and increased demand for the IUD postabortion. Women expressed a clear preference for immediate insertion. Convenience, protection from pregnancy and privacy issues were paramount and women expressed preference for engagement with staff who knew their abortion history, and with whom they had an established connection. Doctors and nurses were generally in favour of immediate insertion and said it could be incorporated into standard care if women wanted this. This contrasted with the need for interventions by the research team to reinforce adherence by staff to provide contraception as allocated during the trial.ConclusionsWomen and staff favour immediate IUD insertion after second trimester medical abortion, but service delivery may require structures that ensure timely insertion postabortion, continuity of care, communication that mitigates loss to follow-up and training of staff to ensure competence.

Project description:ObjectiveTo investigate whether a 20-mL buffered 1% lidocaine paracervical block decreases pain during intrauterine device (IUD) placement.MethodsIn a randomized, single-blind, placebo-controlled trial, women were assigned to receive either a 20-mL buffered 1% lidocaine paracervical block or no block before IUD placement. The primary outcome was pain with IUD placement measured on a 100-mm visual analog scale. Our sample size had 80% power (α=0.05) to detect a 20-mm difference in visual analog scale scores with a SD of 28 mm. Secondary outcomes included pain with speculum placement, paracervical block administration, tenaculum placement, 5 minutes postprocedure, and overall pain perception.ResultsFrom October 7, 2014, through October 26, 2017, 64 women were enrolled and analyzed (33 in the paracervical block arm, 31 in the no-block arm). There were no differences in baseline demographics between the groups. Women who received the paracervical block reported less pain with IUD placement compared with women who received no block (median visual analog scale score of 33 mm vs 54 mm, P=.002). Pain was significantly less in the intervention group for uterine sounding (30 mm vs 47 mm, P=.005), 5 minutes after placement (12 mm vs 27 mm, P=.005), and overall pain perception (30 mm vs 51 mm, P=.015). Participants who received the paracervical block experienced more pain with block administration compared with placebo (30 mm vs 8 mm, P=.003). There was no perceived pain difference for speculum insertion (10 mm vs 6 mm, P=.447) or tenaculum placement (15 mm vs 10 mm, P=.268).ConclusionA 20-mL buffered 1% lidocaine paracervical block decreases pain with IUD placement (primary outcome), uterine sounding (secondary outcome), and 5 minutes after placement (secondary outcome). Although paracervical block administration can be painful, perception of pain for overall IUD placement procedure is lower compared with no block.Clinical trial registrationClinicalTrials.gov, NCT02219308.

Project description:ObjectiveTo document clinical outcomes and women's experiences following the introduction of mifepristone into South African public sector second-trimester medical abortion services, and compare with historic cohorts receiving misoprostol-only.MethodsRepeated cross-sectional observational studies documented service delivery and experiences of women undergoing second-trimester medical abortion in public sector hospitals in the Western Cape, South Africa. Women recruited to the study in 2008 (n = 84) and 2010 (n = 58) received misoprostol only. Those recruited in 2014 (n = 208) received mifepristone and misoprostol. Consenting women were interviewed during hospitalization by study fieldworkers with respect to socio-demographic information, reproductive history, and their experiences with the abortion. Clinical details were extracted from medical charts following discharge. Telephone follow-up interviews to record delayed complications were conducted 2-4 weeks after discharge for the 2014 cohort.ResultsThe 2014 cohort received 200 mg mifepristone, which was self-administered 24-48 hours prior to admission. For all cohorts, following hospital admission, initial misoprostol doses were generally administered vaginally: 800 mcg in the 2014 cohort and 600 mcg in the earlier cohorts. Women received subsequent doses of misoprostol 400 mcg orally every 3-4 hours until fetal expulsion. Thereafter, uterine evacuation of placental tissue was performed as needed. With one exception, all women in all cohorts expelled the fetus. Median time-to-fetal expulsion was reduced to 8.0 hours from 14.5 hours (p<0.001) in the mifepristone compared to the 2010 misoprostol-only cohort (time of fetal expulsion was not recorded in 2008). Uterine evacuation of placental tissue using curettage or vacuum aspiration was more often performed (76% vs. 58%, p<0.001) for those receiving mifepristone; major complication rates were unchanged. Hospitalization duration and extreme pain levels were reduced (p<0.001), but side effects of medication were similar or more common for the mifepristone cohort. Overall satisfaction remained unchanged (95% vs. 91%), while other acceptability measures were higher (p<0.001) for the mifepristone compared to the misoprostol-only cohorts.ConclusionThe introduction of a combined mifepristone-misoprostol regimen into public sector second-trimester medical abortion services in South Africa has been successful with shorter time-to-abortion events, less extreme pain and greater acceptability for women. High rates of uterine evacuation for placental tissue need to be addressed.

Project description:ObjectiveTo assess whether indicators of limited access to services explained changes in rates of second-trimester abortion after implementation of a restrictive abortion law in Texas.MethodsWe used cross-sectional vital statistics data on abortions performed in Texas before (November 1, 2011-October 31, 2012) and after (November 1, 2013-October 31, 2014) implementation of Texas' abortion law. We conducted monthly mystery client calls for information about abortion facility closures and appointment wait times to calculate distance from women's county of residence to the nearest open Texas facility, the number of open abortion facilities in women's region of residence (facility network size), and days until the next consultation visit. We estimated mixed-effects logistic regression models to assess the association between obtaining abortion care after the law's implementation and having a second-trimester abortion (12 weeks of gestation or more), after adjustment for distance, network size, and wait times.ResultsOverall, 64,902 Texas-resident abortions occurred in the period before the law was introduced and 53,174 occurred after its implementation. After implementation, 14.5% of abortions were performed at 12 weeks of gestation or more, compared with 10.5% before the law (P<.001; unadjusted odds ratio [OR] 1.45; 95% CI 1.40-1.50). Adjusting for distance to the nearest facility and facility network size reduced the odds of having a second-trimester abortion after implementation (OR 1.17; 95% CI 1.10-1.25). Women living 50-99 miles from the nearest facility (vs less than 10 miles) had higher odds of second-trimester abortion (OR 1.24; 95% CI 1.11-1.39), as did women in regions with less than one facility per 250,000 reproductive-aged women compared with women in areas that had 1.5 or more facilities (OR 1.57; 95% CI 1.41-1.75). After implementation, women waited 1 to 14 days for a consultation visit; longer waits were associated with higher odds of second-trimester abortion.ConclusionIncreases in second-trimester abortion after the law's implementation were due to women having more limited access to abortion services.

Dataset Information

Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial.

Publications

Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial.

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