Imunofan in risk-stratified obstetric care: 112-woman program
N. Yu. Vladimirova, V. G. Nikitin, G. V. Chizhova · 2023 · Healthcare of the Far East / Zdravookhranenie Dalnego Vostoka. 2023;(2):43–48
Historical human pregnancy exposure · Pregnancy and offspring evidence review ↗
Reported findings and study design
Reported findings
The program reports threatened pregnancy loss falling from 41.3% to 19.6% and preterm birth from 8.7% to 4.7%. Imunofan was an adjunct only in the 36-woman middle-risk protocol; these overall results cannot be assigned to Imunofan.
Risk-stratified clinical program compared with earlier protocols; all groups received immunoglobulin, and the highest-risk group also plasmapheresis. Table 1 labels the n=112 dataset Nikitin 2017, although the article was published in 2023. No randomized Imunofan-only comparator.
Dose, route and schedule
Imunofan intramuscularly in the medium-risk group, 2–4 weeks after completion of first-trimester immunoglobulin treatment. Immunoglobulin courses at weeks 8–12 and 20–24 in that group. Other risk groups followed different protocols; this is a historical bundled-care description.
Protocol source ↗ · Original publisher PDF text, methods, Table 1 and discussion checked via indexed full text; numerical table not visually verified
| Measure | Result | Comparison, timing and statistics |
|---|---|---|
| Threatened pregnancy loss | 41.3% / 19.6% | Table’s without/after immunocorrection columns for the n=112 program; not the n=36 Imunofan subgroup · Table star: p<0.05 |
| Preterm birth | 8.7% / 4.7% | Same whole-program columns; raw event denominators not supplied · Table star: p<0.05 |
| Neonatal morbidity | 638.0 / 264.0 per 1,000 | Morbidity rate, not percentage of infants; multiple diagnoses may occur · Table star: p<0.05 |
| Viral transmission | 54.5% / 18.2% | No significance star for this row; narrative significance claims are broader than table notation |
| Neutral outcomes | No reduction in overall gestational complications or spontaneous pregnancy loss; no significant effect on perinatal mortality | Explicit discussion statement on printed p.47 |
Imunofan-specific effects cannot be isolated: different baseline risks, immunoglobulin exposure, plasmapheresis and historical comparisons confound the program outcomes. The 112 women are not an Imunofan treatment arm. Only the n=36 risk-group protocol explicitly adds it, and subgroup outcomes are not separately supplied. Publication year 2023 is not recruitment year: the outcome table labels these data 2017. No raw outcome counts, confidence intervals or systematic long-term child-safety follow-up were verified. The paper reports important neutral outcomes. Historical exposure does not establish a current indication or safety during pregnancy.
Source for the extracted data ↗ · Checked 2026-11-08
Molekul summary of the linked publication. Educational information, not medical advice. Seek qualified healthcare help for medical conditions.
Methods, limitations & source review
Study limitations
- Imunofan-specific effects cannot be isolated: different baseline risks, immunoglobulin exposure, plasmapheresis and historical comparisons confound the program outcomes.
- The 112 women are not an Imunofan treatment arm. Only the n=36 risk-group protocol explicitly adds it, and subgroup outcomes are not separately supplied.
- Publication year 2023 is not recruitment year: the outcome table labels these data 2017. No raw outcome counts, confidence intervals or systematic long-term child-safety follow-up were verified.
- The paper reports important neutral outcomes. Historical exposure does not establish a current indication or safety during pregnancy.
Publication counts are not counts of independent trials. Reviews, translations and reports sharing participants may overlap. Findings apply to the studied preparation, population and endpoints.
Document format: Original PDF
Review depth: Original publisher PDF text, methods, Table 1 and discussion checked via indexed full text; numerical table not visually verified
Related-report group: pregnancy-imunofan-combined-care-2023. Reports in this group are not assumed to be independent trials.
Source access and review scope
Original publisher PDF text, methods, Table 1 and discussion checked via indexed full text; numerical table not visually verified
Recorded source-check date: 2026-11-08. This date does not imply a completed systematic review.
Source type: Original journal publication
Citation and original source
Original source: N. Yu. Vladimirova, V. G. Nikitin, G. V. Chizhova. Imunofan in risk-stratified obstetric care: 112-woman program Healthcare of the Far East / Zdravookhranenie Dalnego Vostoka. 2023;(2):43–48 2023.
Molekul research summary: https://molekul.io/research/pregnancy-imunofan-combined-care-2023. Cite the original publication for its findings and this page when referring to Molekul’s summary or evidence appraisal.
Bibliography entry