Association of Nausea and Vomiting During Pregnancy With Pregnancy Loss: A Secondary Analysis of a Randomized Clinical Trial.
Association of Nausea and Vomiting During Pregnancy With Pregnancy Loss: A Secondary Analysis of a Randomized Clinical Trial.
- 2016
Conclusions and Relevance: Among women with 1 or 2 prior pregnancy losses, nausea and vomiting were common very early in pregnancy and were associated with a reduced risk for pregnancy loss. These findings overcome prior analytic and design limitations and represent the most definitive data available to date indicating the protective association of nausea and vomiting in early pregnancy and the risk for pregnancy loss. Design, Setting, and Participants: A randomized clinical trial, Effects of Aspirin in Gestation and Reproduction, enrolled women with 1 or 2 prior pregnancy losses at 4 US clinical centers from June 15, 2007, to July 15, 2011. This secondary analysis was limited to women with a pregnancy confirmed by positive results of a human chorionic gonadotropin (hCG) test. Nausea symptoms were ascertained from daily preconception and pregnancy diaries for gestational weeks 2 to 8. From weeks 12 to 36, participants completed monthly questionnaires summarizing symptoms for the preceding 4 weeks. A week-level variable included nausea only, nausea with vomiting, or neither. Importance: Nausea and vomiting during pregnancy have been associated with a reduced risk for pregnancy loss. However, most prior studies enrolled women with clinically recognized pregnancies, thereby missing early losses. Main Outcomes and Measures: Peri-implantation (hCG-detected pregnancy without ultrasonographic evidence) and clinically recognized pregnancy losses. Objective: To examine the association of nausea and vomiting during pregnancy with pregnancy loss. Results: A total of 797 women (mean [SD] age, 28.7 [4.6] years) had an hCG-confirmed pregnancy. Of these, 188 pregnancies (23.6%) ended in loss. At gestational week 2, 73 of 409 women (17.8%) reported nausea without vomiting and 11 of 409 women (2.7%), nausea with vomiting. By week 8, the proportions increased to 254 of 443 women (57.3%) and 118 of 443 women (26.6%), respectively. Hazard ratios (HRs) for nausea (0.50; 95% CI, 0.32-0.80) and nausea with vomiting (0.25; 95% CI, 0.12-0.51) were inversely associated with pregnancy loss. The associations of nausea (HR, 0.59; 95% CI, 0.29-1.20) and nausea with vomiting (HR, 0.51; 95% CI, 0.11-2.25) were similar for peri-implantation losses but were not statistically significant. Nausea (HR, 0.44; 95% CI, 0.26-0.74) and nausea with vomiting (HR, 0.20; 95% CI, 0.09-0.44) were associated with a reduced risk for clinical pregnancy loss. Trial Registration: clinicaltrials.gov Identifier: NCT00467363.
English
2168-6106
*Abortion, Spontaneous/pc [Prevention & Control]
*Anti-Inflammatory Agents, Non-Steroidal/ad [Administration & Dosage]
*Aspirin/ad [Administration & Dosage]
*Nausea/th [Therapy]
*Pregnancy Complications/th [Therapy]
*Vomiting/th [Therapy]
Adolescent
Adult
Anti-Inflammatory Agents, Non-Steroidal/ae [Adverse Effects]
Aspirin/ae [Adverse Effects]
Biomarkers/bl [Blood]
Chorionic Gonadotropin/bl [Blood]
Double-Blind Method
Female
Follow-Up Studies
Humans
Israel
Pregnancy
Pregnancy Outcome
Pregnancy Trimester, First
Pregnancy Trimester, Second
Prospective Studies
Research Design
Risk Assessment
Risk Factors
United States
MedStar Washington Hospital Center
Obstetrics and Gynecology/Maternal-Fetal Medicine
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Conclusions and Relevance: Among women with 1 or 2 prior pregnancy losses, nausea and vomiting were common very early in pregnancy and were associated with a reduced risk for pregnancy loss. These findings overcome prior analytic and design limitations and represent the most definitive data available to date indicating the protective association of nausea and vomiting in early pregnancy and the risk for pregnancy loss. Design, Setting, and Participants: A randomized clinical trial, Effects of Aspirin in Gestation and Reproduction, enrolled women with 1 or 2 prior pregnancy losses at 4 US clinical centers from June 15, 2007, to July 15, 2011. This secondary analysis was limited to women with a pregnancy confirmed by positive results of a human chorionic gonadotropin (hCG) test. Nausea symptoms were ascertained from daily preconception and pregnancy diaries for gestational weeks 2 to 8. From weeks 12 to 36, participants completed monthly questionnaires summarizing symptoms for the preceding 4 weeks. A week-level variable included nausea only, nausea with vomiting, or neither. Importance: Nausea and vomiting during pregnancy have been associated with a reduced risk for pregnancy loss. However, most prior studies enrolled women with clinically recognized pregnancies, thereby missing early losses. Main Outcomes and Measures: Peri-implantation (hCG-detected pregnancy without ultrasonographic evidence) and clinically recognized pregnancy losses. Objective: To examine the association of nausea and vomiting during pregnancy with pregnancy loss. Results: A total of 797 women (mean [SD] age, 28.7 [4.6] years) had an hCG-confirmed pregnancy. Of these, 188 pregnancies (23.6%) ended in loss. At gestational week 2, 73 of 409 women (17.8%) reported nausea without vomiting and 11 of 409 women (2.7%), nausea with vomiting. By week 8, the proportions increased to 254 of 443 women (57.3%) and 118 of 443 women (26.6%), respectively. Hazard ratios (HRs) for nausea (0.50; 95% CI, 0.32-0.80) and nausea with vomiting (0.25; 95% CI, 0.12-0.51) were inversely associated with pregnancy loss. The associations of nausea (HR, 0.59; 95% CI, 0.29-1.20) and nausea with vomiting (HR, 0.51; 95% CI, 0.11-2.25) were similar for peri-implantation losses but were not statistically significant. Nausea (HR, 0.44; 95% CI, 0.26-0.74) and nausea with vomiting (HR, 0.20; 95% CI, 0.09-0.44) were associated with a reduced risk for clinical pregnancy loss. Trial Registration: clinicaltrials.gov Identifier: NCT00467363.
English
2168-6106
*Abortion, Spontaneous/pc [Prevention & Control]
*Anti-Inflammatory Agents, Non-Steroidal/ad [Administration & Dosage]
*Aspirin/ad [Administration & Dosage]
*Nausea/th [Therapy]
*Pregnancy Complications/th [Therapy]
*Vomiting/th [Therapy]
Adolescent
Adult
Anti-Inflammatory Agents, Non-Steroidal/ae [Adverse Effects]
Aspirin/ae [Adverse Effects]
Biomarkers/bl [Blood]
Chorionic Gonadotropin/bl [Blood]
Double-Blind Method
Female
Follow-Up Studies
Humans
Israel
Pregnancy
Pregnancy Outcome
Pregnancy Trimester, First
Pregnancy Trimester, Second
Prospective Studies
Research Design
Risk Assessment
Risk Factors
United States
MedStar Washington Hospital Center
Obstetrics and Gynecology/Maternal-Fetal Medicine
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial