impact of the “39-week rule” on adverse maternal outcomes ... · outcome n (%) n (%) aor (95%...

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Impact of the “39-Week Rule” on Adverse Maternal Outcomes: A Statewide Analysis A. Caroline Cochrane, MD, MSc; Ryan Batson, MD; Meredith Aragon, MD, MPH; Molly Bedenbaugh, BS; Stella Self, PhD; Katheryn Isham, MD; Kacey Eichelberger, MD

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Page 1: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Impact of the “39-Week Rule” on Adverse Maternal Outcomes: A Statewide Analysis

A. Caroline Cochrane, MD, MSc; Ryan Batson, MD; Meredith Aragon, MD, MPH; Molly Bedenbaugh, BS; Stella Self, PhD; Katheryn Isham, MD;

Kacey Eichelberger, MD

Page 2: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Term pregnancy

Viability

(23 weeks)

Late

term

(410 - 416)

Full

term

(390 - 406)

Early

term

(370 - 386)

Late

pre-term

(340 - 366)

Post

term

(420 →)

Increase risk of

stillbirth Increase risk of:

- Pulmonary hypoplasia/RDS

- Necrotizing enterocolitis

- Infection

- Death

Page 3: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Evidence of increased adverse neonatal outcomes with early term delivery

Page 4: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

ACOG & SMFM adopt the “39-week rule”

Page 5: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Medicaid and Blue Cross Blue Shield establish a non-payment policy for elective inductions prior to 39 weeks

Page 6: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Downstream effects

• Some scarce neonatal data available

• Unknown effects on maternal outcomes as a result of increasing gestational age

Page 7: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Objective

• Quantify the differences in adverse maternal outcomes as a result of widespread implementation of the “39-week rule” in South Carolina

Page 8: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Hypothesis

• There has been a shift in adverse maternal outcomes as an unintended consequence of the “39-week rule”

Page 9: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Methods

• Retrospective cohort study

• Term, singleton births in the state of South Carolina

• Group 1: “Pre-implementation” 1/1/2000 – 12/31/2008

• Group 2: “Post-implementation” 1/1/2013 – 12/31/2017

• Obtained all ICD codes, maternal age, race, BMI, and gestational age at time of delivery

• 1 week prior to delivery to 90 days post delivery

• Births having one or more codes for any outcome were counted as having an incidence of that outcome

Page 10: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Composite

Adverse Maternal

Outcomes

Cesarean

DeliveryHypertensive

Disorder

Postpartum

Hemorrhage

Placental

Abruption

Intrahepatic

Cholestasis

ICU

Admission

Blood

Transfusion

High Degree

Laceration

Maternal

Infection

Page 11: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Statistics

• Propensity score analysis was used to control for maternal age, race, and BMI to eliminate confounding data

• Outcome incidences were compared using the Cochran-Mantel-Haenszel(CMH) test, with any p-value <0.05 considered to be significant.

• Adjusted common odds ratio was used to determine direction of the significant differences

• All analysis performed in R version 3.5.2.

Page 12: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Study Population

Page 13: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Group 1

(Delivery between 2000-2008)

n = 412,632

Group 2

(Delivery between 2013-2017)

n = 221,353

P value

Maternal age (years)

< 20 57,846 (14.02%) 16,895 (7.63%) <0.01

20-29 234,447 (56.82%) 125,528 (56.71%) <0.01

30-39 113,681 (27.55%) 74,612 (33.71%) <0.01

> 39 6,658 (1.61%) 4,318 (1.95%) <0.01

Maternal race

Black/African American 136,088 (32.98%) 69,069 (31.20%) <0.01

White/Caucasian 267,133 (64.74%) 146,407 (66.14%) <0.01

Indian 6,045 (1.46%) 5,772 (2.61%) <0.01

Other 3,366 (0.82%) 105 (0.05%) <0.01

Maternal BMI

< 18.5 10,208 (2.47%) 8,383 (3.79%) <0.01

18.5 – 24.9 106,063 (25.7%) 90,210 (40.75%) <0.01

25 – 29.9 224,016 (54.29%) 57,600 (26.02%) <0.01

30 – 34.9 41,617 (10.09%) 33,135 (14.97%) <0.01

35 – 39.9 17,513 (4.24%) 17,616 (7.96%) <0.01

> 39 13,215 (3.2%) 14,409 (6.51%) <0.01

Payor status

Medicaid 118, 528 (28.72%) 115,036 (51.97%) <0.01

Private insurance 91,721 (22.23%) 88,607 (40.03%) <0.01

Self pay 15,993 (3.88%) 6,742 (3.05%) <0.01

Other 13,164 (3.19%) 10,148 (4.58%) <0.01

Unknown 173,226 (41.98%) 820 (0.37%) <0.01

Patient

Demographics

Page 14: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Patient Demographics

Group 1

n = 412,632

N (%)

Group 2

n = 221,353

N (%)

P value

Gestational age at time of

delivery

37w0d-38w6d 139,557 (33.82%) 63,444 (28.66%) <0.01

39w0d-≥ 41w 273,075 (66.18%) 157,909 (71.34%) <0.01

↓ 5.16%

Page 15: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Outcomes of Interest

Group 1

(n=412,632)

Group 2

(n=221,353)

Outcome N (%) N (%) AOR (95% CI) P value

Composite value 164,803 (39.94%) 94,658 (42.76%) 1.0580 (1.0468, 1.0633) <0.01 ↑2.82%

*Controlled for maternal age, race, and BMI

Page 16: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Outcomes of Interest

Group 1

(n=412,632)

Group 2

(n=221,353)

Outcome N (%) N (%) AOR (95% CI) P value

Cesarean delivery 122,116 (29.59%) 70,428 (31.82%) 1.0264 (1.0148, 1.0382) < 0.01

Hypertensive disorder diagnosis 31,960 (7.75%) 22,350 (10.10%) 1.3138 (1.2903, 1.3378) <0.01

Chorioamnionitis 5,982 (1.45%) 4,257 (1.92%) 1.4402 (1.3837, 1.4991) <0.01

Intrahepatic cholestasis 264 (0.06%) 798 (3.63%) 5.2959 (4.6044, 6.0911) <0.01

Blood transfusion 2,815 (0.68%) 2,308 (1.04%) 1.5696 (1.4845, 1.6595) <0.01

ICU admission 4,643 (1.13%) 6,734 (3.04%) 2.5959 (2.4988, 2.6969) <0.01

↑ 2.23%

↑ 2.35%

↑ 0.47%

↑ 3.57%

↑ 0.36%

↑ 1.91%

*Controlled for maternal age, race, and BMI

Page 17: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Outcomes of Interest

Group 1

(n=412,632)

Group 2

(n=221,353)

Outcome N (%) N (%) AOR (95% CI) P value

High degree lacerations* 13,456 (4.63%) 3,898 (2.58%) 0.5405 (0.5211, 0.5605) <0.01 ↓ 2.05%

*Controlled for maternal age, race, and BMI

Page 18: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Outcomes of Interest

Group 1

(n=412,632)

Group 2

(n=221,353)

Outcome N (%) N (%) AOR (95% CI) P value

Postpartum

hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308) 0.9472

Placental abruption 3,016 (0.73%) 1,700 (0.77%) 1.0092 (0.9505, 1.718) 0.7744

*Controlled for maternal age, race, and BMI

Page 19: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Hypertensive DisordersGroup 1

(n=412,632)

Group 2

(n=221,353)

Outcome N (%) N (%) AOR (95% CI) P value

Gestational hypertension

16,425

(3.98%)

12,439

(5.62%)

1.4049

(1.3715, 1.4392) <0.01

Preeclampsia without severe features

10,264

(2.49%)

6,087

(2.75%)

1.1242

(1.0884, 1.1613) <0.01

Preeclampsia with severe features /

HELLP

2,032

(0.49%)

2,046

(0.92%)

1.9231

(1.8070, 2.0468) <0.01

Eclampsia

397

(0.10%)

235

(0.11%)

1.2111

(1.0286, 1.4259) 0.0242

Chronic hypertension with

superimposed preeclampsia

1,216

(0.29%)

1,378

(0.62%)

1.8484

(1.7097, 1.9983) <0.01

Unspecified hypertension in pregnancy

2,871

(0.70%)

1,856

(0.84%)

1.1260

(1.0613, 1.1947) <0.01

↑ 1.64%

↑ 0.26%

↑ 0.43%

↑ 0.01%

↑ 0.33%

↑ 0.06%

*Controlled for maternal age, race, and BMI

Page 20: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Discussion

• Overall number of deliveries in the early term period decreasedsignificantly

• Diagnosis of all hypertensive disorders significantly increased

• Incidence of C-section increased

• Incidence of blood transfusion, ICU admission, maternal infection, IHC increased

• Incidence of high degree lacerations decreased

Page 21: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Strengths

• Large sample size

• Generalizable results

• Changing maternal demographics were controlled

Page 22: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Limitations

• Analysis limited to coding data

• Patient ethnicity information unavailable

• Cannot control for other shifts in population health or physician practice

Page 23: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Conclusions

• Incidence of several adverse maternal outcomes have increased since implementation of the 39-week rule

• This difference persists after controlling for changes in maternal race, age, and BMI

• Cannot control for changes in overall population health

• As the only country in the world with an increasing maternal mortality rate, a much closer look at the 39-week rule is warranted

Page 24: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)

Questions?

https://lovestats.wordpress.com/dman/survey-research-statistics-meme/

Page 25: Impact of the “39-Week Rule” on Adverse Maternal Outcomes ... · Outcome N (%) N (%) AOR (95% CI) P value Postpartum hemorrhage 11,659 (2.83%) 6,173 (2.79%) 0.9988 (0.9678, 1.0308)