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Doula support during first-trimester surgical abortion: a randomized controlled trial.

ABSTRACT: The objective of the study was to evaluate the impact of doula support on first-trimester abortion care.Women were randomized to receive doula support or routine care during first-trimester surgical abortion. We examined the effect of doula support on pain during abortion using a 100 mm visual analog scale. The study had the statistical power to detect a 20% difference in mean pain scores. Secondary measures included satisfaction, procedure duration, and patient recommendations regarding doula support.Two hundred fourteen women completed the study: 106 received doula support, and 108 received routine care. The groups did not differ regarding demographics, gestational age, or medical history. Pain scores in the doula and control groups did not differ at speculum insertion (38.6 [±26.3 mm] vs 43.6 mm [±25.9 mm], P = .18) or procedure completion (68.2 [±28.0 mm] vs 70.6 mm [±23.5 mm], P = .52). Procedure duration (3.39 [±2.83 min] vs 3.18 min [±2.36 min], P = .55) and patient satisfaction (75.2 [±28.6 mm] vs 74.6 mm [±27.4 mm], P = .89) did not differ between the doula and control groups. Among women who received doula support, 96.2% recommended routine doula support for abortion and 60.4% indicated interest in training as doulas. Among women who did not receive doula support, 71.6% of women would have wanted it. Additional clinical staff was needed to provide support for 2.9% of women in the doula group and 14.7% of controls (P < .01).Although doula support did not have a measurable effect on pain or satisfaction, women overwhelmingly recommended it for routine care. Women receiving doula support were less likely to require additional clinic support resources. Doula support therefore may address patient psychosocial needs.

SUBMITTER: Chor J

PROVIDER: S-EPMC4275368 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Doula support during first-trimester surgical abortion: a randomized controlled trial.

Chor Julie J Hill Brandon B Martins Summer S Mistretta Stephanie S Patel Ashlesha A Gilliam Melissa M

American journal of obstetrics and gynecology 20140628 1

<h4>Objective</h4>The objective of the study was to evaluate the impact of doula support on first-trimester abortion care.<h4>Study design</h4>Women were randomized to receive doula support or routine care during first-trimester surgical abortion. We examined the effect of doula support on pain during abortion using a 100 mm visual analog scale. The study had the statistical power to detect a 20% difference in mean pain scores. Secondary measures included satisfaction, procedure duration, and pa ...[more]

PMID: 24983679

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Project description:BACKGROUND:Traditionally the gold-standard technique for the treatment of spontaneous abortion has been uterine evacuation by aspiration curettage. However, many studies have proposed medical treatment with misoprostol as an alternative to the conventional surgical treatment. The aim of this study was to apply cost minimization methods to compare the cost and effectiveness of the use of vaginal misoprostol as a medical treatment for first trimester spontaneous abortion with those of evacuation curettage as a surgical treatment. METHODOLOGY/PRINCIPAL FINDINGS:We present a longitudinal, prospective and quasi-experimental research study including a total of 547 patients diagnosed with first-trimester spontaneous abortion, in the period from January 2013 to December 2015. Patients were offered medical treatment with 800 mg vaginal misoprostol or evacuation curettage. Patients treated with misoprostol were followed-up at 7 days and a transvaginal ultrasound was performed to confirm the success of the treatment. If it failed, a second dose of 800 mg of vaginal misoprostol was prescribed and a new control ultrasound was performed. In case of failure of medical treatment after the second dose of misoprostol, evacuation curettage was indicated. The effectiveness of each of the treatment options was calculated using a decision tree. The cost minimization study was carried out by weighting each cost according to the effectiveness of each branch of the treatment. Of the 547 patients who participated in the study, 348 (64%) chose medical treatment and 199 (36%) chose surgical treatment. The overall effectiveness of medical treatment was 81% (283/348) and surgical treatment of 100%. The estimated final cost for medical treatment was € 461.92 compared to € 2038.72 for surgical treatment, which represents an estimated average saving per patient of € 1576.8. CONCLUSIONS/SIGNIFICANCE:Medical treatment with misoprostol is a cheaper alternative to surgery: in the Spanish Public Healthcare System, it is five times more inexpensive than curettage. Given its success rates higher than 80%, mild side effects, controllable with additional medication and the high degree of overall satisfaction, it should be prioritized over the evacuation curettage in patients who meet the treatment criteria.

Project description:INTRODUCTION:Migrant women consistently rate their care during labour and birth more negatively than non-migrant women, due to communication difficulties, lack of familiarity with how care is provided, and discrimination and prejudicial staff attitudes. They also report being left alone, feeling fearful, unsafe and unsupported, and have poorer birth outcomes than non-migrant women. Community-based doulas (CBDs) are bilingual women from migrant communities who are trained in childbirth and labour support, and who facilitate communication between woman-partner-staff during childbirth. This study protocol describes the design, rationale and methods of a randomised controlled trial that aims to evaluate the effectiveness of CBD support for improving the intrapartum care experiences and postnatal well-being of migrant women giving birth in Sweden. METHODS AND ANALYSIS:A randomised controlled trial. From six antenatal care clinics in Stockholm, Sweden, we aim to recruit 200 pregnant Somali, Arabic, Polish, Russian and Tigrinya-speaking women who cannot communicate fluently in Swedish, are 18 years or older and with no contraindications for vaginal birth. In addition to standard labour support, women are randomised to CBD support (n=100) or no such support during labour (n=100). Trained CBDs meet with women once or twice before the birth, provide emotional, physical and communication support to women throughout labour and birth in hospital, and then meet with women once or twice after the birth. Women's ratings of the intrapartum care experiences and postnatal well-being are assessed at 6-8 weeks after the birth using selected questions from the Migrant Friendly Maternity Care Questionnaire and by the Edinburgh Postnatal Depression Scale. The intervention group will be compared with the control group using intention-to-treat analyses. ORs and 95% CIs will be estimated and adjustments made if key participant characteristics differ between trial arms. ETHICS AND DISSEMINATION:The study was approved by the Regional Ethical Review Board in Stockholm (approval number: 2018/12 - 31/2). TRIAL REGISTRATION NUMBER:NCT03461640; Pre-results.

Project description:STUDY OBJECTIVE:The potential for maternal antidepressant use to influence the risk of spontaneous abortion, one of the most important adverse pregnancy outcomes, is not clear. We aimed to assess whether first trimester antidepressant exposure was associated with an increased risk of spontaneous abortion. DESIGN:Community-based prospective cohort study (Right from the Start). SETTING:Eight metropolitan areas in North Carolina, Tennessee, and Texas. PARTICIPANTS:A total of 5451 women (18 years of age or older) who were planning to conceive or were pregnant (before 12 weeks of completed gestation) and were enrolled in the study between 2000 and 2012; of those women, 223 used antidepressants (selective serotonin reuptake inhibitors [SSRIs] only [170], SSRIs and non-SSRIs [9], and non-SSRIs only [44]) during their first trimester, and 5228 did not (never users). Measurements and Main Results First trimester antidepressant use was determined during a first trimester telephone interview. Spontaneous abortion was self-reported and verified by medical records. The association of first trimester antidepressant use and spontaneous abortion was assessed by using Cox proportional hazard regression. Among the 5451 women enrolled, 223 (4%) reported first trimester antidepressant use, and 659 (12%) experienced a spontaneous abortion. SSRIs were the most common class of antidepressants used (179 [80%]). Compared with women who never used antidepressants during the first trimester of pregnancy, women who reported antidepressant use were 34% (adjusted hazard ratio [aHR] 1.34, 95% confidence interval [CI] 0.97-1.85) more likely to experience a spontaneous abortion after adjusting for covariates. Women who reported ever using SSRIs were 45% (aHR 1.45, 95% CI 1.02-2.06) more likely to experience a spontaneous abortion compared with never users. When time of loss relative to the time of interview was taken into consideration, the association between first trimester SSRI use and spontaneous abortion was significant only among those with losses before the interview (aHR 1.49, 95% CI 1.04-2.13) but was not significant among those with losses after the interview (aHR 0.43, 95% CI 0.06-3.15). CONCLUSION:The association between use of first trimester antidepressants, particularly SSRI use, and spontaneous abortion was significant only among women whose exposure status was assessed after loss. In this instance, reporting bias may create a spurious association. Future studies should take the timing of data collection relative to the timing of loss into consideration.

Project description:BACKGROUND:We describe the rationale and protocol for a randomized noninferiority controlled trial (RCT) to determine if the Flexi-T380(+) copper intrauterine contraceptive device (IUD) is comparable in terms of effectiveness and expulsion rates to the most common Canadian IUD currently in use, NovaT-200, when placed immediately after a first-trimester abortion. METHODS/DESIGN:Consenting women choosing to use an IUD after an abortion for a pregnancy of less than 12 weeks of gestation will be randomized to device-type groups to receive immediate post-abortion placement of either a Flexi-T380(+) IUD, a device for which no current evidence on expulsion or effectiveness rates is available, or the Nova-T200 IUD, the only other brand of copper IUD available in Canada at the time of study initiation. The primary outcome measure is IUD expulsion rate at 1 year. Secondary outcomes include: pregnancy rate, method continuation rate, complication rates (infection, perforation), and satisfaction with contraceptive method. A non-intervention group of consenting women choosing a range of other post-abortion contraception methods, including no contraception, will be included for comparison of secondary outcomes. Web-based contraception satisfaction questionnaires, clinical records, and government-linked health administrative databases will be used to assess primary and secondary outcomes. DISCUSSION:The RCT design, combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry, and hospital records, offers a unique opportunity to determine if a novel IUD has a comparable expulsion rate to that of the current standard IUD in Canada, in addition to the first opportunity to determine pregnancy rate and method satisfaction at 1 year post-abortion for women choosing a range of post-abortion contraceptive options. We highlight considerations of design, implementation, and evaluation of the first trial to provide rigorous evidence for the effectiveness of current Canadian IUDs when inserted after first-trimester abortion. TRIAL REGISTRATION:ClinicalTrials.gov Identifier NCT01174225.

Dataset Information

Doula support during first-trimester surgical abortion: a randomized controlled trial.

Publications

Doula support during first-trimester surgical abortion: a randomized controlled trial.

Similar Datasets

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