INTRO: Over a series of research conference meetings at the Society for Acupuncture Research (SAR) spanning three years, this study engaged conference attendees and online consumer, research and clinical groups in the COMET process to establish the 'Acupuncture sets of trial reported core outcomes' (ASTRO) framework (https://doi.org/10.1101/2025.09.07.25335251). Using this framework we developed core outcome set (COS) extensions, including for acupuncture trials in pregnancy, birth and the early postpartum period. This study reports on the development of the ASTRO-Pregnancy and Birth extension core outcome set.
PURPOSE: Using the COMET methodology and the ASTRO framework, to develop a specific COS for outcomes for clinical trials of acupuncture in pregnancy and birth.
METHODS: We used a multi-method design, including a four-stage consensus process involving practitioners, researchers and patients, to develop the ASTRO framework, and a specific COS for pregnancy and birth outcomes in acupuncture trials (ASTRO-Pregnancy and Birth extension).
• Stage I: A systematic review of the literature across three databases identified all outcomes from acupuncture trials in pregnancy, including safety and feasibility.
• Stage II: Consultation with stakeholders via a roundtable discussion (SAR conference workshop 2023) occurred to refine these measures to develop a set of five comprehensive surveys for outcomes in women’s health conditions, including one relating specifically to pregnancy, birth and the early postpartum period.
• Stage III: The survey was distributed online to research practice and consumer/patient networks, and SAR 2024 conference attendees. Using a modified Delphi method, participants voted on each outcome’s importance on a Likert scale (1 = not important, 9 = critically important). Outcomes averaging =7 progressed to Round 2, where the process was repeated for the survey.
• Stage IV: A final consensus meeting held at the SAR conference 2025, where engaged stakeholders met to reach final consensus for the COS for safety and feasibility outcomes for acupuncture trials in women’s health using the ASTRO framework, and an 'extension' core outcome set for five women’s health conditions, including pregnancy (ASTRO-Pregnancy and Birth), to be used in conjunction with the safety and feasibility outcomes (ASTRO-Safety and feasibility in women’s health).
RESULTS: The process for developing a COS for women's health explored the holistic nature of acupuncture trials to incorporate whole person health outcomes using common themes of pain, sleep, mood, cognition, safety (ASTRO framework). For the pregnancy and birth extension (ASTRO-Pregnancy and Birth), we reviewed 17 papers, providing 141 (round one) and 133 (round 2) outcomes for voting in the two rounds of a modified Delphi survey. From these outcomes, we developed a final set of outcomes in three domains. Domain 1 contained nine specific outcomes which can be included for all acupuncture trials for pregnancy and birth. Domain 2 details nine specific birth characteristic outcomes, and Domain 3 contains eight specific pregnancy and postpartum indications (3.a through to 3.h), each containing separate outcome sets.
The nine core outcomes included in Domain 1, are: 1. Demographic details, 2. satisfaction with total pregnancy/birth experience, 3. pregnancy condition/s, 4. pregnancy complication/s, 5. labor onset and timing, 6. mode of birth, 7. length of hospital stay, 8. neonatal outcomes, and 9. postpartum wellbeing.
These outcomes are an extension of, and used in addition to the main ASTRO COS (doi: 10.1101/2025.09.07.25335251), and the previously developed outcomes covered in the STRICTA and NICMAN framework.
CONCLUSION: This model is highly relevant to inform future acupuncture research in pregnancy, birth and postpartum conditions, commonly criticized for low data quality and heterogeneity of outcomes. Using international conference meetings to conduct studies using the COMET methodology offers a unique opportunity for researchers, practitioners and consumers/patients to come together for information gathering, data collection and analysis, and final consensus forums to establish the COS with multidisciplinary input. This study used the COMET methodology and the ASTRO framework to develop a core outcome set for acupuncture trials in pregnancy, birth and the early postpartum period.
PI and supervisor: 1. Kate Levett, PhD, MPH, B.Ed (Hons I), Adv.Dip.App.Sci (Acup), School of Medicine, University of Notre Dame Australia
Student 1. 2. Valentina Buay, BSc (Medical Science, Hons I), School of Medicine, University of Notre Dame Australia
Supervisor 3. Claudia Citkovitz, PhD, MS, Lac, Director, Acupuncture Services, Research Assistant Professor, Department of Rehabilitation Medicine, NYU Medical School, ccitkovitz@gmail.com
4. Kathleen Lumiere, DAOM, Mac, LAc, Clinical Supervisor and Faculty, Bastyr University, klumiere@bastyr.edu
5. Rosa Schnyer, DAOM, IFMCP, LAc, School of Nursing, University of Texas, Austin rschnyer@utexas.edu
6. Debra Betts, PhD Debra Betts, PHD, LAc, Adjunct Research Fellow, NICM Health Research Institute, Western Sydney University debra.betts@rhizome.net.nz
7. Sandro Graca, MSc, Lic TCM, FABORM, Lecturer and Researcher, School of Health and Society, Faculty of Education, Health and Wellbeing, University of Wolverhampton
Student 2. 8. Wen Tu, BSN, MMSc, College of Nursing, University of Utah, u1412475@utah.edu
9. Belinda J. Anderson, PhD, LAc, College of Health Professions, Pace University and Albert Einstein College of Medicine
10. Lisa Conboy, MA, MS, ScD, Beth Israel Deaconess Medical Center, Harvard Medical School; Director of Academic Research, Maryland University of Integrative Health
Supervisor 2. 11. Lisa Taylor-Swanson, PhD, MAcOM, LAc, College of Nursing, University of Utah
Disease Category: Pregnancy & childbirth
Disease Name: Childbirth, Pregnancy
Age Range: 17 - 45
Sex: Female
Nature of Intervention: Complementary and alternative medicine (CAM) therapy
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Governmental agencies
- Journal editors
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- Service providers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Consensus meeting
- Delphi process
- Focus group(s)
- Literature review
- Semi structured discussion
- Survey
We used a multi-method design, including a four-stage consensus process involving practitioners, researchers and patients to develop the ASTRO framework, and a specific COS for pregnancy, birth and postpartum outcomes in acupuncture trials (ASTRO-Pregnancy and Birth extension).
• Stage I: A systematic review of the literature across three databases identified all outcomes from acupuncture trials in women’s health
• Stage II: Consultation with stakeholders via a meeting and roundtable discussion (conference workshop 2023) and development of five comprehensive surveys for outcomes in women’s health conditions, including one relating specifically to pregnancy, birth and the early postpartum period.
• Stage III: Survey distribution online to research practice and consumer/patient networks, and SAR 2024 conference attendees. Using a modified Delphi method, participants voted on each outcome’s importance on a Likert scale (1 = not important, 9 = critically important). Outcomes averaging =7 progressed to Round 2, where the process was repeated for the survey.
• Stage IV: A final consensus meeting held at the SAR conference 2025, where engaged stakeholders met to reach final consensus for the COS for safety and feasibility outcomes for acupuncture trials in women’s health using the ASTRO framework and an 'extension' core outcome set for five women’s health conditions, including pregnancy (ASTRO-Pregnancy and Birth), to be used in conjunction with the safety and feasibility outcomes (ASTRO-Safety and feasibility in women’s health).