Clinical Research Directory

Healthy Expectancy Through Routine Antenatal STI Screening

This study will evaluate whether routine screening and treatment for two common sexually transmitted infections, chlamydia and gonorrhoea, during pregnancy can reduce preterm birth and other poor birth outcomes in Botswana, and whether this approach is affordable and cost-effective for the health system. About 2,000 pregnant women attending their first antenatal care visit at up to 10 government clinics in Botswana will be invited to join the study. All women will first receive the usual antenatal care services provided in Botswana, including routine health checks and HIV and syphilis testing. Women who enroll in the study will be randomly assigned to one of two groups: 1. Standard of care group: Women receive routine antenatal care only. 2. Intervention group: In addition to routine antenatal care, women are screened for chlamydia and gonorrhoea using self-collected vaginal swabs at their first antenatal care visit and again in the third trimester. The main outcome of the study is whether screening and treating chlamydia and gonorrhoeae reduces preterm birth (before 37 weeks). Other outcomes include low birth weight, very preterm birth, and maternal health conditions.

Exploring Reproductive Health Among Women in Somaliland

Somaliland faces persistently high burdens of maternal and perinatal mortality, with limited population-based data on pregnancy complications, sociocultural influence on maternal health, and women's reproductive health needs across the continuum of pregnancy, childbirth, and postpartum. Existing maternal near-miss (MNM) tools are largely facility-based, and evidence of postpartum contraceptive uptake and interventions remains scarce. In response, the objective of this study is to unfold the physical, cultural, and psychosocial strengths and challenges experienced by women in Somaliland during pregnancy, childbirth, and the postpartum period; to examine how these factors interact to influence pregnancy outcomes and women's ability to achieve future reproductive health goals; and to pilot how these insights can inform the co-creation of context-appropriate health materials. The PROMISE study is a community-based longitudinal pregnancy cohort in Hargeisa, Somaliland, including approximately 800 pregnant women \<28 weeks of gestation recruited from randomly selected sub-districts. Women will be followed up at three time points (early pregnancy, late pregnancy, and postpartum) using questionnaires and clinical measurements. A MNM tool will be adapted through a Delphi process, and its validity will be tested using the cohort. The cohort findings will inform a co-creation process to develop postpartum contraceptive counselling materials to be pilot-tested for feasibility, acceptability, and preliminary effects. This protocol responds to major evidence gaps in fragile and low-resource contexts, and aims to generate contextually grounded knowledge and co-created interventions to strengthen maternal health policy, practice, and reproductive agency in Somaliland and beyond.

Addressing Pregnant Women's First Trimester Worries and Information Needs With mHealth Solutions

The first 12 weeks of pregnancy, known as the first trimester, can be one of the most worrying times for women. (Where this lay summary refers to women, it should be taken to include people who do not identify as women but who have the capacity to become pregnant). Many experience nausea, bleeding, or anxiety about whether the pregnancy is progressing normally. Despite this, most women do not see a midwife or doctor until around 10 weeks into the pregnancy. This leaves a gap where they may have important questions but little professional support. As a result, many turn to mobile phone applications or the internet to find answers - but the quality of information online is mixed, and it can be confusing or even unsafe. This research aims to understand what support women really need in early pregnancy, what concerns they have, and whether a mobile health application (mHealth app) could help fill this gap in current pregnancy care in a safe and personalised way. The study will also ask healthcare professionals and digital health experts what such an application should include, and how it can be made accessible, and easy to understand for all women - including those with different levels of health knowledge and digital skills. To carry out the research, we will use a combination of online surveys and interviews. Women who are currently pregnant or have had a baby in the last two years will be invited to take part, along with healthcare professionals such as midwives and doctors, and experts in digital health. The survey will ask about their experiences in early pregnancy, how they have used digital tools or apps, and whether they felt their questions were answered before their first NHS appointment. The interview stage will allow participants to talk in more depth about what support they wanted and what would have helped them most. All participants will receive information about support services because we realise that discussing unmet information needs or worries in early pregnancy may be upsetting for some women. The views collected will inform the design of a new mobile application to support women during early pregnancy. The application will use artificial intelligence (AI) to personalise information based on each woman's needs and background, and to explain things clearly and simply. The content and design of the application will be reviewed by doctors and digital health specialists to make sure it is safe, accurate, and easy to use. Public and patient involvement is central to this project. A diverse group of women and representatives from grassroots organisations will be invited to shape the questions we ask, review the design of the application, and help us make it inclusive for people from different backgrounds. This research will help us create a practical, trustworthy, and inclusive tool to support women during one of the most vulnerable times in pregnancy when women don't usually see a doctor. If successful, it could be used widely across the NHS to help reduce anxiety, improve understanding, and ensure women get the right support earlier in their pregnancy with the long-term aim of improving outcomes for women, babies, and families across the UK.

A Culturally Adapted Digital Intervention to Promote Maternal Care Utilization Using Multifaceted Approaches

Maternal healthcare utilization is crucial for reducing maternal mortality, yet remains low in many underserved regions. The CALCIUM intervention, a culturally tailored, digital platform-integrated intervention, was developed to promote antenatal care (ANC) and institutional deliveries in Liangshan Yi Autonomous Prefecture, an ethnic minority community in China. The CALCIUM intervention was developed to address barriers including limited healthcare awareness, traditional norms and low-quality services. This intervention will evaluate the effectiveness, and cost-effectiveness of improving maternal healthcare utilization and pregnancy outcomes in an ethnic minority community.

An Evaluation of the Effectiveness of a Maternal, Neonatal and Child Health Component for Matasa Matan Arewa and Smart Start Targeting Married Adolescent Girls in Nigeria and Ethiopia

Evidence on the effectiveness of interventions aimed at creating demand and access to pre-conceptual and antenatal care (ANC) among adolescent girls and young women (AGYW) from sub-Saharan Africa is scarce. A program called Adolescents 360 (A360) led by Population Services International in Nigeria, Ethiopia, Kenya and Tanzania supports adolescent girls to identify contraceptives as a relevant tool for enabling them to pursue their self-defined life aspirations. Avoiding or delaying childbirth is crucial for AGYW to pursue their life goals, but motherhood remains a vital aspiration for many. A360 respects these aspirations and supports AGYW to pursue motherhood when the time comes, safely and aligning with their unique preferences. In 2022, A360 set out to design a maternal, neonatal and child health (MNCH) component that would be layered to the existing sexual and reproductive health interventions in Ethiopia and Nigeria. A360 employed human-centered design (HCD) to design these components. The implementation of these components in real-world settings began in 2023. A360 has designed an evaluation to determine the effectiveness of the MNCH components in improving the AGYW's comprehensive knowledge of what is needed to pursue healthy pregnancies, increase their self-efficacy to access ANC and garner support from their key influencers in the process of pursuing healthy pregnancies. The evaluation's primary objective is to determine the effectiveness of the MNCH components at increasing comprehensive knowledge, self-efficacy and key influencer support to pursue healthy pregnancies among married AGYW in Nigeria and Ethiopia. The secondary objectives are: (a) to evaluate the component's effectiveness at increasing comprehensive knowledge of what care is required to attain healthy pregnancies, (b) to evaluate the component's effectiveness at increasing self-efficacy to attend ANC, (c) to determine the component's efficacy at eliciting support from AGYW's key influencers when they are pursuing healthy pregnancies, and (d) to surface the system-level barriers, facilitators, and opportunities for program improvement during the implementation of the MNCH components. The MNCH components are implemented in Kaduna and Jigawa states in Nigeria and in Oromia, Sidama, Amhara, South and Central regions in Ethiopia. The evaluation is based in the same geographies where the components are implemented. The evaluation uses an implementation-effectiveness hybrid design, blending an outcome evaluation and an implementation science component. The outcome evaluation constitutes of a quantitative survey using a longitudinal approach with two study arms, an intervention, and a comparison arm. It has three assessments: a recruitment phase, and two follow-ups (3 months after recruitment and 8 weeks post-partum (only for pregnant AGYW). Participant recruitment is conducted using recruitment scripts after obtaining oral consent and the administration of a set of screening questions to assess eligibility. Full consenting procedures are executed and written consent obtained prior to involvement in any of the evaluation components. A structured questionnaire is used to gather quantitative data from the survey using a Computer Assisted Personal Interview (CAPI) approach. Furthermore, FGD, IDI and KII facilitation guides are used to gather qualitative data. During this process, all sessions are audio-recorded. Audio records are transcribed verbatim and translated. Data is collected by trained enumerators and qualitative researchers who are certified to conduct human subjects' research. Analysis of quantitative data will follow a repeated measures approach employing generalized estimating equations. The repeated measurements of each subject will be made at two times. Between group t-tests and chi-square tests of comparison will be conducted to identify secondary outcomes which show statistically significant differences between participants in the intervention and comparison arms. The qualitative data transcripts will be rigorously analyzed using NVivo or Dedoose. Open-coding and closed-coding will be utilized to identify themes in the qualitative data. Claim statements attributing change to key intervention drivers will be drawn from narrative stories of program beneficiaries guided by the intervention's theory of change. The evaluation received ethical approvals from Ethiopian Midwives Association (EMwA) Institutional Review Commitee (IRC) and the PSI Research Ethics Board (REB) prior to the enumerators training and field data collection. Subsequently, the ethical approval letters were submitted to the sub-national health departments for their reference and support in the management of the field work.