Pregnancy Outcomes in Women with PCOS: Follow-Up Study of a Randomized Controlled Three-Component Lifestyle Intervention
Abstract
:1. Introduction
2. Materials and Methods
2.1. Trial Design
2.2. Participants
2.3. Three-Component Lifestyle Intervention (LSI) and Control Group (CAU)
2.4. Clinical and Endocrine Assessments
2.5. Outcome Measures
2.6. Statistical Methods
3. Results
3.1. Conception Resulting in Live Birth
3.2. Pregnancy and Neonatal Complications
3.3. Prediction of Conception
3.4. Drop-Out Rate during Study Intervention Period
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Lifestyle Intervention (SMS+ and SMS−) n = 123 | Care as Usual n = 60 | |
---|---|---|
n (%) | n (%) | |
Nulliparous | 94 (77.7) | 44 (75.9) |
Smoking | 24 (19.7) | 14 (23.7) |
Alcohol consumption | 27 (22.1) | 19 (32.2) |
Ethnicity | ||
Northern European | 52 (42.6) | 24 (40.0) |
Mediterranean | 18 (14.8) | 12 (20.0) |
Hindustani | 15 (12.3) | 6 (10.0) |
African | 27 (22.1) | 17 (28.3) |
Asian | 6 (4.9) | 0 (0.0) |
Other | 4 (3.3) | 1 (1.7) |
Education | ||
Low | 10 (8.3) | 8 (14.3) |
Intermediate | 67 (55.4) | 35 (62.5) |
High | 44 (36.4) | 13 (23.2) |
PCOS characteristics | ||
OD | 118 (96.7) | 57 (95.0) |
HA | 97 (80.2) | 47 (78.3) |
PCOM | 118 (98.3) | 59 (98.3) |
Phenotype classification | ||
A (OD + HA + PCOM) | 89 (74.8) | 43 (71.7) |
B (OD + HA) | 2 (1.7) | 1 (1.7) |
C (HA + PCOM) | 4 (3.4) | 3 (5.0) |
D (OD + PCOM) | 24 (20.2) | 13 (21.7) |
Median (IQR) | ||
Age (year) | 29 (26–32) | 28 (26–32) |
Weight (kg) | 92 (83–105) | 84 (79–97) |
BMI (kg/m²) | 33.6 (30.8–36.6) | 30.6 (29.3–34.3) |
Waist (cm) | 101 (93–107) | 96 (89–109) |
Age of menarche (year) | 12 (12–14) | 12 (11–13) |
Time attempting to conceive (months) | 24 (15–38) | 23 (14–35) |
Lifestyle Intervention (SMS+ and SMS−) | Care as Usual | Total | ||
---|---|---|---|---|
n (%) | n (%) | p | n (%) | |
Conception resulting in live birth | 49/123 (39.8) | 23/60 (38.3) | 0.845 | 72/183 (39.3) |
Stillbirth (ante partum) | - | - | - | 3/75 (4.0) |
Mode of conception | ||||
Spontaneous | 27/49 (55.1) | 15/23 (65.2) | 42/72 (58.3) | |
After ART | 16/49 (32.7) | 7/23 (30.4) | 23/72 (31.9) | |
Unknown | 6/49 (12.2) | 1/23 (4.3) | 0.521 | 7/72 (9.7) |
Method of delivery | ||||
Vaginal birth | 25/49 (51.0) | 11/23 (47.8) | 36/72 (50.0) | |
Instrument-assisted/caesarean section | 22/49 (44.9) | 12/23 (52.2) | 34/72 (47.2) | |
Unknown | 2/49 (4.1) | 0/23 (0.0) | 0.564 | 2/72 (2.8) |
Pregnancy complications | ||||
(gestational) diabetes | 4/49 (8.2) | 5/23 (21.7) | 0.133 | 9/72 (12.5) |
Hypertensive disorders | 4/49 (8.2) | 3/23 (13.0) | 0.673 | 7/72 (9.7) |
Preterm birth | 6/49 (12.2) | 4/23 (17.4) | 0.716 | 10/72 (13.9) |
Adverse postpartum outcomes | ||||
Hemorrhage | - | - | - | 5/72 (6.9) |
Adverse neonatal outcomes | ||||
Apgar score < 7 after 5 min | - | - | - | 3/72 (4.2) |
NICU admission | 3/49 (6.1) | 3/23 (13.0) | 0.376 | 6/72 (8.3) |
Small for gestational age | 6/49 (12.2) | 4/23 (17.4) | 0.716 | 10/72 (13.9) |
Large for gestational age | 5/49 (10.6) | 4/23 (17.4) | 0.452 | 9/72 (12.5) |
Congenital abnormalities | - | - | - | 5/72 (6.9) |
Median (IQR) | Median (IQR) | |||
Birth weight (grams) | 3350 (2915–3760) | 3260 (2790–3870) | 0.668 | |
Birth weight (percentile) | 64 (24–83) | 69 (22–86) | 0.817 | |
Gestational age at delivery (days) | 276 (264–283) | 276 (267–283) | 0.633 | |
Apgar 5 min | 10 (9–10) | 10 (9–10) | 0.734 |
Univariate Model | OR (95% CI) | p-Value |
---|---|---|
Age | 0.939 (0.875–1.007) | 0.078 |
Body mass index | 0.877 (0.776–0.991) | 0.035 |
Modified Ferriman–Gallwey score | 0.959 (0.901–1.021) | 0.191 |
Waist circumference | 0.967 (0.930–1.006) | 0.094 |
Time attempting to conceive | 0.984 (0.971–0.997) | 0.014 |
Androstenedione | 0.906 (0.805–1.021) | 0.105 |
Free androgen index | 0.919 (0.852–0.992) | 0.030 |
Glucose | 0.564 (0.310–1.023) | 0.060 |
Insulin | 0.992 (0.986–0.997) | 0.002 |
Sex hormone-binding globulin | 1.020 (1.000–1.040) | 0.049 |
Mean ovarian volume | 0.925 (0.846–1.013) | 0.091 |
Amenorrhea | 0.535 (0.223–1.287) | 0.163 |
Multivariate model | OR (95% CI) | p-value |
Time attempting to conceive | 0.984 (0.972–0.997) | 0.017 |
Insulin | 0.991 (0.986–0.997) | 0.003 |
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Dietz de Loos, A.; Jiskoot, G.; Louwers, Y.; Beerthuizen, A.; Busschbach, J.; Laven, J. Pregnancy Outcomes in Women with PCOS: Follow-Up Study of a Randomized Controlled Three-Component Lifestyle Intervention. J. Clin. Med. 2023, 12, 426. https://doi.org/10.3390/jcm12020426
Dietz de Loos A, Jiskoot G, Louwers Y, Beerthuizen A, Busschbach J, Laven J. Pregnancy Outcomes in Women with PCOS: Follow-Up Study of a Randomized Controlled Three-Component Lifestyle Intervention. Journal of Clinical Medicine. 2023; 12(2):426. https://doi.org/10.3390/jcm12020426
Chicago/Turabian StyleDietz de Loos, Alexandra, Geranne Jiskoot, Yvonne Louwers, Annemerle Beerthuizen, Jan Busschbach, and Joop Laven. 2023. "Pregnancy Outcomes in Women with PCOS: Follow-Up Study of a Randomized Controlled Three-Component Lifestyle Intervention" Journal of Clinical Medicine 12, no. 2: 426. https://doi.org/10.3390/jcm12020426