Table 4 Cumulative Obstetric and Perinatal Outcomes (Intention-to-Treat Analysis)

From: Effect of single blastocyst-stage versus single cleavage-stage embryo transfer on cumulative live births in women with good prognosis undergoing in vitro fertilization: Multicenter Randomized Controlled Trial

Outcomes, No./total (%)

Blastocyst-stage embryo transfer group (n = 497)

Cleavage-stage embryo transfer group (n = 495)

Absolute differencea(95% CI)

Relative risk (95% CI)

P value

Live births outcomes

Gestational age, mean (SD), weeks

38.8 (1.7)

38.9 (1.7)

−0.1 (−0.4 to 0.1)

-

0.40

Birthweight, mean (SD), grams

 Singleton

     

 No of observations

363

324

   

 Mean weight

3357.6 (505.0)

3333.7 (526.5)

23.9 (−53.4 to 101.2)

-

0.54

 Twin

 No of observations

18

8

   

 Mean weight

2388.3 (650.5)

2088.8 (622.6)

299.6 (−263.9 to 863.0)

-

0.28

Low birth weightb

18 (3.6)

18 (3.6)

−0.0 (−2.3 to 2.3)

1.00 (0.52 to 1.89)

0.99

Very low birth weightc

5 (1.0)

4 (0.8)

0.2 (−1.0 to 1.4)

1.24 (0.34 to 4.61)

1.00

Macrosomiad

33 (6.6)

36 (7.3)

−0.6 (−3.8 to 2.5)

0.91 (0.58 to 1.44)

0.70

Small for gestational agee

23 (4.6)

20 (4.0)

0.6 (−1.9 to 3.1)

1.15 (0.64 to 2.06)

0.65

Large for gestational agef

63 (12.7)

54 (10.9)

1.8 (−2.2 to 5.8)

1.16 (0.83 to 1.63)

0.39

Sex ratio

 Male

206/381(54.1)

164/332(49.4)

4.7 (−2.7 to 12.0)

1.09 (0.95 to 1.26)

0.21

 Female

175/381(45.9)

168/332(50.6)

   

Live birth without a complication

130 (26.2)

118 (23.8)

2.3 (−3.1 to 7.7)

1.10 (0.88 to 1.36)

0.40

Maternal complications

Gestational diabetes mellitus

54 (10.9)

55 (11.1)

−0.2 (−4.1 to 3.6)

0.98 (0.69 to 1.39)

0.90

Preeclampsia or eclampsia

5 (1.0)

14 (2.8)

−1.8 (−3.5 to −0.1)

0.36 (0.13 to 0.98)

0.04

Gestational hypertension

20 (4.0)

17 (3.4)

0.6 (−1.8 to 2.9)

1.17 (0.62 to 2.21)

0.62

Preterm premature rupture of membraneg

25 (5.0)

8 (1.6)

3.4 (1.2 to 5.6)

3.11 (1.42 to 6.83)

0.003

Premature rupture of membrane

51 (10.3)

37 (7.5)

2.8 (−0.7 to 6.3)

1.37 (0.92 to 2.06)

0.12

Preterm birthh

30 (6.0)

18 (3.6)

2.4 (−0.3 to 5.1)

1.66 (0.94 to 2.94)

0.08

Spontaneous preterm birthi

23 (4.6)

10 (2.0)

2.6 (0.4 to 4.8)

2.29 (1.10 to 4.76)

0.02

Iatrogenic preterm birthj

7 (1.4)

8 (1.6)

−0.2 (−1.7 to 1.3)

0.87 (0.32 to 2.38)

0.79

Very preterm birth ( < 32 Weeks)k

5 (1.0)

4 (0.8)

0.2 (−1.0 to 1.4)

1.24 (0.34 to 4.61)

1.00

Placenta previa

8 (1.6)

2 (0.4)

1.2 (−0.0 to 2.4)

3.98 (0.85 to 18.67)

0.11

Placental abruption

3 (0.6)

2 (0.4)

0.2 (−0.7 to 1.1)

1.49 (0.25 to 8.90)

1.00

Placental accreta

12 (2.4)

6 (1.2)

1.2 (−0.5 to 2.9)

1.99 (0.75 to 5.27)

0.16

Other placental abnormality

11 (2.2)

8 (1.6)

0.6 (−1.1 to 2.3)

1.37 (0.56 to 3.38)

0.49

Postpartum hemorrhage

10 (2.0)

17 (3.4)

−1.4 (−3.4 to 0.6)

0.59 (0.27 to 1.27)

0.17

Neonatal complications

Therapeutic abortion or fetal reduction due to fetal congenital anomalies during 12 to 28 weeks of gestationl

6 (1.2)

4 (0.8)

0.4 (−0.8 to 1.6)

1.49 (0.42 to 5.26)

0.76

Stillbirth

8 (1.6)

4 (0.8)

0.8 (−0.6 to 2.2)

1.99 (0.60 to 6.57)

0.25

Neonatal hospitalization > 3 days

57 (11.5)

31 (6.3)

5.2 (1.7 to 8.7)

1.83 (1.20 to 2.79)

0.004

Neonatal jaundice

119 (23.9)

101 (20.4)

3.5 (−1.6 to 8.7)

1.17 (0.93 to 1.48)

0.18

Neonatal infection

24 (4.8)

11 (2.2)

2.6 (0.3 to 4.9)

2.17 (1.08 to 4.39)

0.03

Neonatal death among live newborns

1 (0.2)

2 (0.4)

−0.2 (−0.9 to 0.5)

0.50 (0.05 to 5.47)

1.00

Congenital anomalyl

16 (3.2)

10 (2.0)

1.2 (−0.8 to 3.2)

1.59 (0.73 to 3.48)

0.24

Participants with at least one of the maternal or neonatal complicationsm

253 (50.9)

217 (43.8)

7.1 (0.9 to 13.3)

1.16 (1.02 to 1.32)

0.03

  1. SD standard deviation. Two-sided P values. No adjustments were made for multiple comparisons. Two-sample t-test was used for continuous variable; Chi-square test or Fisher’s Exact Test was used for categorical data.
  2. aAbsolute differences in percentages are indicated in percentage points, and absolute differences in other values are indicated in units of that value.
  3. bLow birth weight was defined as a value of <2500 g.
  4. cVery low birth weight was defined as a value of <1500 g.
  5. dMacrosomia was defined as a value of >4000 g.
  6. eBirthweight lower than the 10th percentile.
  7. fBirthweight higher than the 90th percentile.
  8. gPreterm premature rupture of membrane in the table refers to premature rupture of membrane before 37 weeks gestational age.
  9. hPreterm birth was defined as delivery at less than 37 weeks gestational age.
  10. iSpontaneous preterm birth was defined as preterm delivery due to spontaneous labor resulting from preterm premature rupture of membranes, cervical factors and other reasons.
  11. jIatrogenic preterm birth was defined as a preterm birth resulting from a planned delivery due to maternal and/or fetal complications, including labor induction or cesarean section.
  12. kVery preterm birth was defined as delivery at less than 32 weeks gestational age.
  13. lDetails of congenital anomaly were listed in Supplementary Table 7.
  14. mMaternal complications include gestational diabetes mellitus, preeclampsia or eclampsia, gestational hypertension, premature rupture of membrane, preterm birth, placenta previa, placental abruption, placental accreta, other placental abnormality, and postpartum hemorrhage. Neonatal complications include therapeutic abortion or fetal reduction due to fetal congenital anomalies during 12 to 28 weeks of gestation, stillbirth, neonatal hospitalization > 3 days, neonatal jaundice, neonatal infection, neonatal death among live newborns, congenital anomaly, low birth weight, macrosomia, small for gestational age, and large for gestational age.
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