Table 2.
Maternal and Fetal or Neonatal Outcomes.*
| Outcome | Prenatal Surgery (N = 78) | Postnatal Surgery (N = 80) | Relative Risk (95% CI) | P Value |
|---|---|---|---|---|
| Maternal outcome | ||||
| Chorioamniotic membrane separation — no. (%) | 20 (26) | 0 | NA | <0.001 |
| Pulmonary edema — no. (%) | 5 (6) | 0 | NA | 0.03 |
| Modified biophysical profile <8 — no. (%)† | 13 (17) | 6 (8) | 2.22 (0.89–5.55) | 0.08 |
| Oligohydramnios — no. (%) | 16 (21) | 3 (4) | 5.47 (1.66–18.04) | 0.001 |
| Placental abruption — no. (%) | 5 (6) | 0 | NA | 0.03 |
| Gestational diabetes — no. (%) | 4 (5) | 5 (6) | 0.82 (0.23–2.94) | 1.00 |
| Chorioamnionitis — no. (%) | 2 (3) | 0 | NA | 0.24 |
| Preeclampsia or gestational hypertension — no. (%) | 3 (4) | 0 | NA | 0.12 |
| Spontaneous membrane rupture — no. (%) | 36 (46) | 6 (8) | 6.15 (2.75–13.78) | <0.001 |
| Spontaneous labor — no. (%) | 30 (38) | 11 (14) | 2.80 (1.51–5.18) | <0.001 |
| Blood transfusion at delivery — no. (%) | 7 (9) | 1 (1) | 7.18 (0.90–57.01) | 0.03 |
| Status of hysterotomy site at delivery — no./total no. (%) | ||||
| Intact, well-healed | 49/76 (64) | |||
| Very thin | 19/76 (25) | |||
| Area of dehiscence | 7/76 (9) | |||
| Complete dehiscence | 1/76 (1) | |||
| Fetal or neonatal outcome | ||||
| Bradycardia during fetal or neonatal repair — no. (%) | 8 (10) | 0 | NA | 0.003 |
| Perinatal death — no. (%) | 2 (3) | 2 (2) | 1.03 (0.14–7.10) | 1.00 |
| Gestational age at birth — wk | 34.1±3.1 | 37.3±1.1 | <0.001 | |
| Gestational age at birth — no. (%) | <0.001‡ | |||
| <30 wk | 10 (13) | 0 | ||
| 30–34 wk | 26 (33) | 4 (5) | ||
| 35–36 wk | 26 (33) | 8 (10) | ||
| ≥37 wk | 16 (21) | 68 (85) | ||
| Birth weight | ||||
| Mean — g | 2383±688 | 3039±469 | <0.001 | |
| Less than 3rd percentile — no. (%) | 0 | 2 (2) | NA | 0.50 |
| Less than 10th percentile — no. (%) | 3 (4) | 7 (9) | 0.45 (0.12–1.66) | 0.33 |
| Dehiscence at repair site — no./total no. (%) | 10/77 (13) | 5/80 (6) | 2.05 (0.73–5.73) | 0.16 |
| Apnea — no./total no. (%) | 28/77 (36) | 18/80 (22) | 1.62 (0.98–2.67) | 0.06 |
| Pneumothorax — no./total no. (%) | 1/77 (1) | 1/80 (1) | 1.05 (0.07–16.53) | 1.00 |
| Respiratory distress syndrome — no./total no. (%)§ | 16/77 (21) | 5/80 (6) | 3.32 (1.28–8.63) | 0.008 |
| Patent ductus arteriosus — no./total no.(%)¶ | 3/77 (4) | 0 | NA | 0.12 |
| Sepsis — no./total no. (%)║ | 4/77 (5) | 1/80 (1) | 4.16 (0.48–36.36) | 0.20 |
| Necrotizing enterocolitis — no./total no. (%)** | 1/77 (1) | 0 | NA | 0.49 |
| Periventricular leukomalacia — no./total no. (%) | 4/77 (5) | 2/80 (2) | 2.08 (0.39–11.02) | 0.44 |
| Foot deformity — no./total no. (%) | 39/78 (50) | 36/80 (45) | 1.11 (0.80–1.54) | 0.53 |
Plus–minus values are means ±SD. There were no instances of bronchopulmonary dysplasia, pulmonary interstitial emphysema, retinopathy of prematurity, pulmonary hypoplasia, grade 3 or 4 intraventricular hemorrhage, or confirmed seizures in either group. Data for neonatal outcomes are listed for 77 infants in the prenatal-surgery group, since 1 infant was stillborn. Additional rare adverse events are provided in the Supplementary Appendix, along with adverse events for 25 additional randomized patients and their offspring (median follow-up from randomization, 29.9 weeks) who underwent randomization on or after July 1, 2009. Percentages may not total 100 because of rounding. NA denotes not applicable.
The modified biophysical profile is a test of fetal well-being that is calculated on the basis of results of ultrasonography evaluating the presence of fetal breathing, movement, and tone, along with the amniotic fluid index. The highest possible score is 8.
The between-group comparison was performed with the use of the Cochran–Armitage test for trend.
Respiratory distress syndrome was defined as a clinical diagnosis of the respiratory distress syndrome type I and the need for oxygen therapy (fraction of inspired oxygen, ≥0.40) at 24 hours of age or more.
Patent ductus arteriosus was reported if the infant was treated with medications or surgery.
Sepsis was defined as confirmation on blood culture, confirmed urinary tract infection, meningitis, or pneumonia.
Necrotizing enterocolitis was defined as a confirmed clinical diagnosis with any of the following findings observed on radiography, at the time of surgery, or at autopsy: unequivocal presence of intramural air, perforation, erythema and induration of the abdominal wall, intraabdominal abscess formation, or the formation of a stricture after an episode of suspected necrotizing enterocolitis.