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Table 4 Outcomes to 28 days after delivery

From: Progesterone in women with arrested premature labor, a report of a randomised clinical trial and updated meta-analysis

 

Progesterone

n = 19

Placebo

n = 22

p-value*

Median/Mean/Risk Difference

(95% Confidence Interval)*

Primary outcome

 Median Gestational age at delivery (weeks and days)

36+2 (IQR 7+4)

Range 26+6 to 41+2

36+4 (IQR 8+0)

Range 24+3 to 41+2

0.865

−0+2

(−3+1 to 2+3)

 Mean Latency from randomization to delivery (days)

44.5 (SD 35.6)

Range 0 to 113

46.6 (SD 29.9)

Range 2 to 116

0.841

−2.1

(−22.8 to 18.6)

Secondary outcomes

 Maternal outcomes

  Gestational age at delivery <37 weeks

11 (57.9%)

11 (50.0%)

0.758

7.9%

(−23.1% to 38.0%)

  Gestational age at delivery <35 weeks

8 (42.1%)

9 (40.9%)

>0.999

1.2%

(−29.5% to 31.4%)

  Gestational age at delivery <34 weeks

7 (36.8%)

8 (36.4%)

>0.999

0.5%

(−30.0% to 30.4%)

  Tocolytics at any time during this pregnancy

   Yes

14 (77.8%)

16 (84.2%)

0.693

−6.4%

(−36.3% to 26.3%)

   No

4 (22.2%)

3 (15.8%)

   Unknown

1

3

  PPROM

   Yes

3 (16.7%)

4 (18.2%)

>0.999

−1.5%

(−32.0% to 28.8%)

   No

15 (83.3%)

18 (81.8%)

   Unknown

1

0

  Betamethasone treatment

   Yes

15 (93.8%)

18 (94.7%)

>0.999

−1.0%

(−33.1% to 31.6%)

   No

1 (6.3%)

1 (5.3%)

   Unknown

3

3

  Mode of delivery

   Vaginal

9 (47.4%)

16 (72.7%)

0.493

14.1%

(−16.5% to 43.2%)

   Operative vaginal

3 (15.8%)

1 (4.6%)

   Cesarean Section

7 (36.8%)

5 (22.7%)

  Delivery complications

   None

15 (83.3%)

18 (90.0%)

0.653

6.7%

(−24.7% to 38.1%)

   Hypertension

0 (0.0%)

1 (5.0%)

   AP bleed

0 (0.0%)

1 (5.0%)

   Othera

3 (16.7%)

0 (0.0%)

   Unknown

1

2

 Infant outcomes

  Median Birth weight (grams)

2625 (IQR 1340)

Range 750 to 3766

(missing = 1)

2660 (IQR 1555)

Range 670 to 3955

0.734

−105

(−739 to 506)

  Adverse outcomes

  

0.732

9.5%

(−23.9% to 41.1%)

   One or more

10 (66.7%)

12 (57.1%)

   None

5 (33.3%)

9 (42.9%)

   Unknown

4

1

  Description of outcomes (could be more than one)

  

   Stillbirth/neonatal death

0

0

   BPD

0

3

   IVH

0

0

   NEC

0

1

   RDS

4

7

   Apnea/bradycardia

1

2

   Jaundice/hyperbilirubinemia

4

6

   Suspected sepsis

2

2

   Transient tachypnea

1

2

   Otherb

8

20

   On ventilator

0

4

  Median Baby length of stay (days)

6 (IQR 29)

Range 0 to 86

(missing = 3)

3 (IQR 38)

Range 1 to 127

(missing = 4)

0.903

0

(−15 to 10)

  1. a Other includes: 3rd degree tear, maternal pancreatitis, and assisted breech extraction
  2. b Other in Group A includes: ventriculomegaly, admission to nicu (reason unknown), hypoglycemia, ROP, pulmonary insufficiency, GERD, esophageal atrenia, bilateral echogenic kidneys, PDA, positive enterobacter CONS tracheal aspirate, edema, hyperkalemia, anemia, metabolic acidosis, acute renal insufficiency, nephrocalcinosis, HMD, bilateral inguinal hernia, SGA, RT hydro ureter. Other in Group B includes: hypoglycemia, small cleft palate, hypovolemia, query infection, hypotension, minor hypospadius, oral aversion, SGA
  3. * Fisher’s exact test for categorical variables, Mann-Whitney U test or t-test for continuous variables; Risk difference and exact 95% confidence limits for categorical variables, Hodges-Lehmann estimation of location shift (median of differences) or difference in means and 95% confidence limits for continuous variables