Monthly obstetrics and gynecology bulletin — September 28, 2026

Period covered: August 29 to September 28, 2026. Note for the month: it was a thin month for large randomized trials in our specialty; the most solid material came from reference reviews, regulatory decisions and surgical series. Several primary sources (The Lancet, Wiley, JAMA, PubMed, Medscape) blocked automated access, so only items whose date and data could be confirmed at the source or in an official summary are included. Searches in Japanese, Chinese, Korean, Russian, Arabic, Turkish and Portuguese returned no verifiable studies within the window beyond those cited; nothing was added as filler.

Obstetrics and maternal-fetal medicine

1. Lancet Seminar on preeclampsia: updated definition, prediction and prevention

[Publication] [Canada / United Kingdom]
Seminar in The Lancet (2026;408:847-60) led from the University of Ottawa, with coauthors from King's College London, Brazil and Australia and a patient advocacy collaborator group. It consolidates the definition without mandatory proteinuria (hypertension ≥20 weeks plus maternal organ or uteroplacental dysfunction), a prevalence of 2-4% of pregnancies, the sFlt-1/PlGF ratio ≤38 with a 99.3% negative predictive value for ruling out preeclampsia within 7 days, and aspirin ≤150 mg at night started before 16 weeks (~62% reduction in preterm preeclampsia, ASPRE). It recommends planned birth at ≥37 weeks, expectant management to 33+6 weeks and individualized decisions at 34-36+6; calcium only when intake is ≤900 mg/day.
Why it matters: it is a narrative review with no new data, but it is the reference synthesis of the year, and its algorithm (early aspirin, angiogenic markers to rule out) applies to the Dominican setting, where hypertensive disorders remain the leading cause of maternal death.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01071-8/abstract

2. RSVpreF vaccination in pregnancy: high infant effectiveness, weak signals for preterm birth and hypertension

[Meta-analysis] [Turkey]
Systematic review and meta-analysis of 24 studies (9 randomized trials with ~18,600 pregnant women and 15 observational studies of Abrysvo) published September 18 in Frontiers in Public Health (authors from Kocaeli City Hospital; online August 25). Effectiveness against infant RSV hospitalization: 79.7% (95% CI 73.9-84.2) at 3 months and 68.1% (57.1-76.3) at 6 months. In the trials, preterm birth was more frequent with the vaccine (RR 1.17; 95% CI 1.03-1.32), non-significant after excluding GSK's GRACE trial (1.10; 0.95-1.27). A second meta-analysis (Alami et al., Vaccine, August 29) describes a signal of more hypertensive disorders of pregnancy after RSVpreF; its figures could not be verified because the source was blocked.
Why it matters: infant protection is well established; the safety signals are weak, depend on heterogeneous studies, and one of the reviews used a single human reviewer assisted by AI, but they reinforce the 32-36-week window and blood pressure surveillance.
https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2026.1935421/full
https://pubmed.ncbi.nlm.nih.gov/42667900/

3. Dominican Republic: 98 maternal deaths through week 35, 21.6% fewer than in 2025

[Publication] [Dominican Republic]
Epidemiological bulletin of the Ministry of Public Health (SINAVE), week 35, released September 18: 98 cumulative maternal deaths in 2026 versus 125 in the same period of 2025 (−21.6%); 4 maternal deaths in week 35. Infant deaths 1,291 versus 1,337, more than 60% neonatal. Reported notification coverage of 92% of facilities. Leading causes cited: hypertensive disorders, hemorrhage, sepsis, complications of unsafe abortion and delayed referral.
Why it matters: these are provisional surveillance counts without denominators (no ratio per 100,000 live births) and under-reporting is not addressed, but the downward trend has held since the week 33 bulletin (−25%), and the top three diagnoses are exactly those covered by items 1 and 2 of this bulletin.
https://www.infobae.com/republica-dominicana/2026/09/18/republica-dominicana-registro-cuatro-muertes-maternas-y-30-fallecimientos-infantiles-en-una-semana/

Gynecologic oncology

4. EMA (CHMP) recommends approval of senaparib as first-line maintenance in advanced ovarian cancer

[Regulatory EMA] [China / European Union]
Positive CHMP opinion of September 18 for senaparib (Sepalna, IMPACT Therapeutics/Pharmanovia), based on the phase 3 FLAMES trial (NCT04169997): 404 patients with FIGO stage III-IV high-grade ovarian, fallopian tube or primary peritoneal cancer in response after platinum, randomized 2:1 to senaparib (n=271) or placebo (n=133). Median progression-free survival not reached versus 13.6 months (HR 0.43; 95% CI 0.32-0.58; p<0.0001); 24-month PFS 63.0% versus 31.3%. Grade ≥3 adverse events: 66.3% versus 20.3% (anemia, thrombocytopenia, neutropenia).
Why it matters: it would be the fourth PARP inhibitor in Europe, but the population was almost exclusively Chinese, there are no overall survival data, severe hematologic toxicity is high and the CHMP opinion is not yet the final approval; it does not change practice relative to olaparib or niraparib.
https://www.onclive.com/view/eu-approval-reccomended-by-chmp-for-senaparib-in-advanced-ovarian-cancer

5. L-MOCA: 51-month overall survival with maintenance olaparib in platinum-sensitive relapse in Asian women

[Publication] [China / Malaysia]
Single-arm phase 3b trial at 37 centers in China and Malaysia (Journal of Ovarian Research 2026;19:243; coverage September 28): 224 patients with high-grade serous or endometrioid ovarian cancer in platinum-sensitive relapse, ≥2 prior lines, PARP inhibitor-naive. Median overall survival 51.0 months (95% CI 42.7-56.1); 64.4 months with a BRCA mutation versus 40.9 without; 54.4 with HRD-positive versus 34.8 with HRD-negative tumors. Median PFS 16.2 months (12.5-18.2).
Why it matters: it confirms the SOLO2/Study 19 figures in an Asian population, but it is a study without a comparator, with 56.7% survival maturity and AstraZeneca/MSD sponsorship; its value is consistency, not novelty.
https://www.onclive.com/view/olaparib-maintenance-yields-promising-long-term-os-outcomes-in-asian-patients-with-platinum-sensitive-relapsed-ovarian-cancer

6. FDA authorizes the pivotal (IDE) study of a blood test for ovarian cancer screening in average-risk women

[Regulatory FDA] [United States]
Mercy BioAnalytics press release of September 21: the FDA approved the investigational device exemption to start the prospective SOARA study (Safety in Ovarian Cancer for Average-Risk Women – Analysis) of the Evident test, based on biomarker colocalization on extracellular vesicles (Mercy Halo platform), which already held Breakthrough Device designation.
Why it matters: this is permission to investigate, not an approval; the release gives no sample size, endpoints or prior sensitivity/specificity, and today there is no approved or recommended ovarian cancer screening test for the general population (UKCTOCS was negative). It is a preview of what is coming, not a reason to change practice.
https://www.biospace.com/press-releases/mercy-bioanalytics-receives-fda-approval-to-initiate-prospective-pivotal-study-of-evident-ovarian-cancer-screening-test

7. Korea: endometrial cancer up 5.6-fold in 24 years according to the national registry

[Publication] [Korea]
Press report (September 3) on the fourth installment of the 2026 women's cancer report, with data from the Korea National Cancer Registry: endometrial cancer cases rose from 721 in 1999 to 2,986 in 2019 and 4,037 in 2023 (2.9% of female cancers; age-standardized rate 15.7 per 100,000 women), peaking in the sixth decade (34.8%) with 17.5% in the fifth. Attributed to a westernized diet, obesity, aging and a longer reproductive span.
Why it matters: it is a news report on registry data, without confidence intervals or trend analysis, but it illustrates the same epidemiological transition already seen in Latin America and argues for a lower threshold for endometrial biopsy in women with obesity and abnormal bleeding (source in Korean).
https://supple.kr/news/cmtkl5g9i000mmeq13g8jw4kz

Reproduction and gynecologic endocrinology

8. Preimplantation genetic testing does not reduce the transfers needed for a live birth with donor eggs

[Publication] [United States]
Retrospective cohort from a large U.S. academic-affiliated center (2016-2024) in the September issue of Fertility and Sterility (2026;126:527-533): 629 donor-oocyte recipients (312 with PGT-A, 317 without) and 927 transfers. Primary outcome: number of transfers to first live birth, median of 1 in both groups; PGT-A was not associated with fewer transfers (HR 0.89) or with differences in time to live birth or miscarriage rate.
Why it matters: retrospective, single-center and with survivor bias (only women who achieved a live birth), but consistent with the biology: with young oocytes aneuploidy is low and PGT-A adds cost and embryo discard without clear benefit; a useful argument against offering it by default in egg donation.
https://www.emjreviews.com/reproductive-health/news/genetic-embryo-testing-shows-no-live-birth-advantage-with-donor-eggs/

9. Vitrified versus fresh donor oocytes: less than a 2-point live-birth difference in the Australia and New Zealand registry

[Publication] [Australia / New Zealand]
ANZARD registry cohort 2009-2023 (Fitzgerald et al., Fertility and Sterility, September issue; data per the ASRM official summary of September 6): more than 2,000 cycles with vitrified donor oocytes versus about 100,000 with fresh; the live-birth rate favored fresh oocytes by less than 2 percentage points, with a number needed to treat of 53 transfers for one additional live birth.
Why it matters: a retrospective registry with confounding by donor and recipient selection, and the figures come from the society's summary rather than the full article; even so, it supports vitrified oocyte banks as a reasonable alternative, with a logistical advantage for small programs such as those in the Dominican Republic.
https://www.asrm.org/news-and-events/podcasts/fertility-and-sterility-on-air/fertility-and-sterility-on-air---toc-september-2026/

10. FDA accepts for review the 3-to-6-year extension of the Miudella copper IUD (Sebela/Organon)

[Regulatory FDA] [United States]
Organon press release of September 14: the FDA accepted Sebela Women's Health's supplemental application to extend the approved duration of Miudella (a low-copper IUD on a nitinol frame, approved in 2025 for 3 years) to 6 years; a decision is expected in the second quarter of 2027. The 3-year data come from three trials in 1,904 women aged 17 to 45 (single-arm phase 3 at 42 sites): cumulative Pearl Index 1.05 (95% CI 0.66-1.60) in ages 17-35, placement success ~99%, discontinuation for bleeding or pain 8.5% in the first year, expulsion 1.9%. Organon licensed global rights in June 2026 and expects launch in late 2026.
Why it matters: the release presents no data for years 4 to 6, and the product requires REMS certification and carries a boxed warning for improper insertion; it is notable as the first new copper IUD in 40 years in the U.S., but it is not yet available in the region.
https://www.organon.com/news/organon-announces-us-fda-has-accepted-for-review-a-supplemental-new-drug-application-for-miudella-a-hormone-free-intrauterine-device/

11. Menopause leaves a blood proteomic signature associated with brain aging and Alzheimer's risk

[Publication] [United States]
Nature Medicine, September 22 (UCSF, Stanford, UC Santa Barbara), open access. Discovery in 80 women aged 43-58 staged with STRAW+10 (118-protein central nervous system panel) and validation in 2,814 women aged 45-60 from the UK Biobank; 16 inflammatory, synaptic and metabolic proteins (including p-tau231) rose from pre- to postmenopause, with a score that increased stepwise (post versus peri β=2.20; p=0.00005), was associated with FSH (β=1.29) and showed no age correlation in men. In four cohorts of older women (n=11,925) the score was associated with a worse cognitive trajectory (ADNI β=−0.30) and with incident Alzheimer's dementia in the UK Biobank (HR 1.15; 95% CI 1.01-1.31; p=0.04).
Why it matters: observational and cross-sectional in the discovery phase, with a modest effect and a confidence interval lower bound near 1; it did not evaluate hormone therapy as an intervention, so it should be used neither to promote nor to discourage it; it is a mechanistic hypothesis, not clinical guidance.
https://www.nature.com/articles/s41591-026-04648-4

Minimally invasive surgery and pelvic floor

12. Laparoscopic sacrocolpopexy in 400 women: 7.8% recurrence and improved urgency, but 23% de novo stress incontinence

[Publication] [Spain]
Single-center retrospective series published online September 24 in the International Urogynecology Journal: 400 consecutive laparoscopic sacrocolpopexies, median follow-up 30 months (IQR 15-48). Overall prolapse recurrence 7.8%. Stress incontinence fell from 38% preoperatively to 29%; urgency incontinence from 41% to 15%. Among symptomatic women, stress incontinence persisted in 38% and appeared de novo in 23%; urgency incontinence persisted in 23% and was de novo in 9%. No external funding.
Why it matters: no comparator and heterogeneous follow-up, but the de novo stress incontinence figure (nearly 1 in 4) is a concrete number for informed consent and for deciding whether to add a sling in the same procedure.
https://link.springer.com/article/10.1007/s00192-026-06905-z

13. Laparoscopic lateral suspension, pectopexy and sacrocolpopexy: similar 12-month apical success in a Turkish cohort

[Publication] [Turkey]
Propensity-weighted retrospective cohort published online September 18 in the International Urogynecology Journal: sacrocolpopexy (n=58), pectopexy (n=63) and lateral suspension (n=67) for apical prolapse. Anatomical apical success at 12 months 74.1% versus 73.0% versus 80.6%, with no significant pairwise differences. The authors acknowledge wide intervals, no prespecified non-inferiority margin, and power only for differences of ~18 points.
Why it matters: it does not demonstrate equivalence or justify abandoning sacrocolpopexy as the standard; it argues that alternative fixation techniques (useful when the promontory is inaccessible) deserve a randomized trial, not a change in the technique of choice.
https://link.springer.com/article/10.1007/s00192-026-06839-6

14. FDA clears the miniaturized MIRA robot (Virtual Incision) for benign hysterectomy

[Regulatory FDA / Industry] [United States]
Virtual Incision press release of August 25 (34 days before this bulletin's cutoff): 510(k) clearance of the MIRA Surgical System, a miniaturized robot inserted through a single incision, for benign hysterectomy, based on a prospective IDE study performed by five surgeons at three U.S. hospitals. The device already held De Novo authorization for colectomy (2024). No n, outcomes or gynecologic launch date were reported.
Why it matters: it is the first low-profile robotic alternative to the large platforms in gynecology, but without published efficacy or complication data and with availability limited to the U.S.; for our setting it matters as a cost trend, not as a short-term option.
https://virtualincision.com/virtual-incision-receives-fda-510k-clearance-for-the-mira-surgical-system-in-benign-hysterectomy-procedures/

Cross-cutting

15. ACOG Clinical Practice Guideline on obstetric cerclage (September 2026)

[Guideline] [United States]
ACOG published in September a Clinical Practice Guideline titled "Obstetric Cerclage" (indexed in PubMed, PMID 42623688). The content is behind restricted access and could not be verified for this edition, so no specific recommendations are cited.
Why it matters: flagged only so the group can consult it directly; until it is read, no change from ACOG's previous cerclage guidance should be assumed.
https://www.acog.org/clinical/clinical-guidance/clinical-practice-guideline/articles/2026/09/obstetric-cerclage

Regional note: no verifiable in-window studies were found in sources from Japan, China, Russia, the Middle East or Brazil (searches in those languages returned guidelines and consensus statements from 2025 or earlier months). The only Turkish endometriosis candidate (an 82-case series) fell two days outside the window and was excluded.

Upcoming meetings and dates

• September 29 to October 3: 20th IMS World Congress on Menopause, Rio de Janeiro, Brazil.
• October 4 to 7: 35th ESGE Annual Congress, Kraków, Poland.
• October 20 to 24: The Menopause Society Annual Meeting, San Diego, USA.
• October 23 to 27: ESMO Congress 2026, Madrid, Spain (gynecologic tumor sessions; the phase 2 FRUTD trial in platinum-resistant ovarian cancer is already listed).
• October 24 to 28: 82nd ASRM Scientific Congress, Baltimore, USA.
• November 13 to 16: 55th AAGL Global Congress, Boston, USA.
  (ESGO 2026 and ISUOG 2026 have already taken place; dates for IGCS, FIGO, RCOG, AUGS/IUGA, FLASOG and SEGO could not be confirmed.)

Monthly obstetrics and gynecology bulletin — September 28, 2026
15 verified items from the past month: The Lancet, Nature Medicine, Fertility and Sterility, International Urogynecology Journal, Frontiers in Public Health, EMA and FDA decisions, and Dominican Ministry of Health surveillance.
Three worth your time:
• Lancet Seminar on preeclampsia: sFlt-1/PlGF ≤38 rules out with 99.3% NPV, and aspirin ≤150 mg before 16 weeks cuts preterm preeclampsia by ~62%. Narrative review, no new data.
• RSV vaccination in pregnancy (24 studies): 79.7% effectiveness against infant hospitalization, but preterm birth RR 1.17 (1.03–1.32) in trials. A weak signal that reinforces the 32–36-week window.
• Laparoscopic sacrocolpopexy in 400 women: 7.8% recurrence and 23% de novo stress incontinence. Single-center retrospective series, but a useful number for counseling.
Full bulletin, with a critical reading of each study and links to primary sources:
https://boletinesmedicos.com/en/obgyn/2026-09-28.html
#ObGyn #Obstetrics #Gynecology #Preeclampsia #Urogynecology

OB/GYN bulletin, Sept 2026: Lancet updates preeclampsia (sFlt-1/PlGF ≤38, NPV 99.3%); RSV vaccine in pregnancy 79.7% effective for infants with a preterm signal, RR 1.17. 15 items, critically read: https://boletinesmedicos.com/en/obgyn/2026-09-28.html