Reiss Kate, Andersen Kathryn, Barnard Sharmani, Ngo Thoai D, Biswas Kamal, Smith Christopher, Carpenter James, Church Kathryn, Nuremowla Sadid, Pearson Erin
Department of Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Ipas, P.O. Box 9990, Chapel Hill, NC, 27515, USA.
BMC Public Health. 2017 Oct 3;17(1):769. doi: 10.1186/s12889-017-4703-z.
Adoption of modern contraceptive methods after menstrual regulation (MR) is thought to reduce subsequent unwanted pregnancy and abortion. Long-acting reversible contraceptives (LARCs) are highly effective at reducing unintended pregnancy, but uptake in Bangladesh is low. Providing information on the most effective methods of contraception increases uptake of more effective methods. This protocol describes a randomised controlled trial of an intervention delivered by mobile phone designed to support post-MR contraceptive use in Bangladesh.
This is a multi-site single blind individual randomised controlled trial. At least 960 women undergoing MR procedures at selected facilities will be recruited after their procedure by female research assistants. Women will be randomised into the control or intervention group with a 1:1 ratio. All participants will receive usual clinic care, including contraceptive counselling and the telephone number of a non-toll-free call centre which provides counselling on MR and contraception. During the 4 months after their MR procedure, intervention participants will be sent 11 recorded interactive voice messages to their mobile phone about contraception with a focus on their chosen method and LARCs. Each message allows the participant to connect directly to the call centre. The intervention is free to the user. The control group will receive no messages delivered by mobile phone. All participants will be asked to complete an in-person questionnaire at recruitment and follow-up questionnaires by telephone at 2 weeks, 4 months and 12 months after their MR. The primary outcome for the trial will be self-reported LARC use 4 months post-MR. Secondary outcomes include LARC use at 2 weeks and 12 months post-MR, use of any effective modern contraceptive method at 2 weeks, 4 months and 12 months post-MR, and contraceptive discontinuation, contraceptive method switching, pregnancy, subsequent MR and experience of violence during the 12 month study period.
Mobile phones offer a low-cost mechanism for providing individualised support to women with contraception outside of the clinic setting. This study will provide information on the effects of such an intervention among MR clients in Bangladesh.
Trial registered with clinicaltrials.gov Registration number: NCT02579785 Date of registration: 16th October 2015.
月经调节（MR）后采用现代避孕方法被认为可减少后续意外怀孕和堕胎情况。长效可逆避孕法（LARC）在减少意外怀孕方面非常有效，但在孟加拉国的使用率较低。提供最有效的避孕方法信息可提高更有效方法的使用率。本方案描述了一项通过手机进行干预的随机对照试验，旨在支持孟加拉国月经调节后的避孕措施使用。
这是一项多中心单盲个体随机对照试验。在选定机构接受月经调节手术的至少960名女性将在术后由女性研究助理招募。女性将以1:1的比例随机分为对照组或干预组。所有参与者将接受常规门诊护理，包括避孕咨询以及一个提供月经调节和避孕咨询的非免费呼叫中心的电话号码。在月经调节手术后的4个月内，干预组参与者将收到11条关于避孕的录音互动语音信息到其手机上，重点是她们选择的方法和长效可逆避孕法。每条信息都允许参与者直接连接到呼叫中心。该干预对用户免费。对照组将不会收到通过手机发送的信息。所有参与者将被要求在招募时填写一份面对面问卷，并在月经调节后2周、4个月和12个月通过电话填写后续问卷。试验的主要结局将是月经调节后4个月自我报告的长效可逆避孕法使用情况。次要结局包括月经调节后2周和12个月的长效可逆避孕法使用情况、月经调节后2周、4个月和12个月使用任何有效的现代避孕方法的情况，以及在12个月研究期间的避孕措施停用、避孕方法转换、怀孕、后续月经调节和暴力经历。
手机为在诊所环境之外为女性提供个性化避孕支持提供了一种低成本机制。本研究将提供关于这种干预对孟加拉国月经调节客户的影响的信息。
在clinicaltrials.gov注册的试验 注册号：NCT02579785 注册日期：2015年10月16日。
