Pregnancy Outcomes According to the Gestational Age of Acquiring COVID-19

Covid19 Clinical Trial

Official title:

Pregnancy Outcomes According to the Gestational Age of Acquiring COVID-19 : an International Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779749
• Other study ID #: PregOutCOV
• Status: Completed
• Start date: December 8, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2021
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A new coronavirus, called severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) appeared in Wuhan, China and it arrived to Europe 2-3 months later. It infected millions of persons and led to the death of thousands until May 2020 where numbers of infections per week decreased significantly. However, starting September, number of infections started to escalate again and continued to rise until now.

Hundreds of good quality articles were published during this period to study the relationship and effects of this virus on pregnancy and vice versa, as well as to determine the adverse neonatal and obstetrical outcomes following the infection. In a case-control study using propensity score matching at the level of age, body mass index and comorbidities (diabetes, hypertension, asthma), pregnant women over 20 week's gestation had significantly higher risk for intensive care unit stay, endotracheal intubation, hospitalization for disease related symptoms and need for oxygen therapy. A new systematic review also demonstrated increased risk for ICU admission in pregnant women compared to non-pregnant women and to non-infected pregnant women.

On the other hand, many researchers have demonstrated that the rates of preterm delivery and cesarean delivery have increased as well, others reported a close relation between SARS-CoV2 infection and preeclampsia or preeclampsia like condition. Enormous effort was done in order to understand adverse outcomes related to this infection, however, most studies included patients in the third or late second trimester. Few studies stratified adverse outcomes of the patients according to the trimester of infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10925
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Pregnant women with viable fetus after 10 weeks' gestation and known pregnancy outcome during the period starting on February 1st 2020 and ending on November 30th 2020.

Exclusion Criteria:

All ongoing pregnancies, those with unknown outcomes, those terminated medically or voluntary, as well as patients with spontaneous abortion before the 11th gestational week.

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• Data extraction from medical files
Data extraction from medical files

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels
France	Antoine Béclère Hospital	Clamart
France	Hôpital Louis Mourier	Colombes
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Countries where clinical trial is conducted

Belgium,  France,  Italy, 

References & Publications (7)

Allotey J, Stallings E, Bonet M, Yap M, Chatterjee S, Kew T, Debenham L, Llavall AC, Dixit A, Zhou D, Balaji R, Lee SI, Qiu X, Yuan M, Coomar D, Sheikh J, Lawson H, Ansari K, van Wely M, van Leeuwen E, Kostova E, Kunst H, Khalil A, Tiberi S, Brizuela V, Broutet N, Kara E, Kim CR, Thorson A, Oladapo OT, Mofenson L, Zamora J, Thangaratinam S; for PregCOV-19 Living Systematic Review Consortium. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020 Sep 1;370:m3320. doi: 10.1136/bmj.m3320. — View Citation

Badr DA, Mattern J, Carlin A, Cordier AG, Maillart E, El Hachem L, El Kenz H, Andronikof M, De Bels D, Damoisel C, Preseau T, Vignes D, Cannie MM, Vauloup-Fellous C, Fils JF, Benachi A, Jani JC, Vivanti AJ. Are clinical outcomes worse for pregnant women at =20 weeks' gestation infected with coronavirus disease 2019? A multicenter case-control study with propensity score matching. Am J Obstet Gynecol. 2020 Nov;223(5):764-768. doi: 10.1016/j.ajog.2020.07.045. Epub 2020 Jul 27. — View Citation

Berghella V, Boelig R, Roman A, Burd J, Anderson K. Decreased incidence of preterm birth during coronavirus disease 2019 pandemic. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100258. doi: 10.1016/j.ajogmf.2020.100258. Epub 2020 Oct 15. — View Citation

Cosma S, Carosso AR, Cusato J, Borella F, Carosso M, Bovetti M, Filippini C, D'Avolio A, Ghisetti V, Di Perri G, Benedetto C. Coronavirus disease 2019 and first-trimester spontaneous abortion: a case-control study of 225 pregnant patients. Am J Obstet Gynecol. 2021 Apr;224(4):391.e1-391.e7. doi: 10.1016/j.ajog.2020.10.005. Epub 2020 Oct 8. — View Citation

Khalil A, von Dadelszen P, Draycott T, Ugwumadu A, O'Brien P, Magee L. Change in the Incidence of Stillbirth and Preterm Delivery During the COVID-19 Pandemic. JAMA. 2020 Jul 10. doi: 10.1001/jama.2020.12746. [Epub ahead of print] — View Citation

Mendoza M, Garcia-Ruiz I, Maiz N, Rodo C, Garcia-Manau P, Serrano B, Lopez-Martinez RM, Balcells J, Fernandez-Hidalgo N, Carreras E, Suy A. Pre-eclampsia-like syndrome induced by severe COVID-19: a prospective observational study. BJOG. 2020 Oct;127(11):1374-1380. doi: 10.1111/1471-0528.16339. Epub 2020 Jun 21. — View Citation

Prabhu M, Cagino K, Matthews KC, Friedlander RL, Glynn SM, Kubiak JM, Yang YJ, Zhao Z, Baergen RN, DiPace JI, Razavi AS, Skupski DW, Snyder JR, Singh HK, Kalish RB, Oxford CM, Riley LE. Pregnancy and postpartum outcomes in a universally tested population for SARS-CoV-2 in New York City: a prospective cohort study. BJOG. 2020 Nov;127(12):1548-1556. doi: 10.1111/1471-0528.16403. Epub 2020 Aug 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm delivery	Delivery at a gestational age < 37 weeks	5 minutes
Primary	Preeclampsia	Preeclampsia is defined as elevated blood pressure (Systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg on at least 2 occasions at least 4 hours apart after 20 weeks of gestation in a previously normotensive patient) and the new onset of 1 or more of the following: Proteinuria =0.3 g in a 24-hour urine specimen or protein/creatinine ratio =0.3 (mg/mg) (30 mg/mmol) in a random urine specimen or dipstick =2+ if a quantitative measurement is unavailable; Platelet count <100,000/microL; Serum creatinine >1.1 mg/dL (97.2 micromol/L) or doubling of the creatinine concentration in the absence of other renal disease; Liver transaminases at least twice the upper limit of the normal concentrations for the local laboratory; Pulmonary edema; New-onset and persistent headache not accounted for by alternative diagnoses and not responding to usual doses of analgesics; Visual symptoms (eg, blurred vision, flashing lights or sparks, scotomata)	5 minutes
Primary	Eclampsia	Eclampsia is defined by the occurrence of a grand mal seizure in a woman with preeclampsia in the absence of other neurologic conditions that could cause seizure.	5 minutes
Primary	Hemolysis Elevated Liver enzymes Low Platelets Syndrome (HELLP)	HELLP syndrome is considered to be a serious complication or variant of preeclampsia in pregnant women.	5 minutes
Primary	Number of participants with Cesarean delivery (CD)	Number of participants with Cesarean delivery (CD)	5 minutes
Primary	Percentage of participants with Cesarean delivery (CD)	Percentage of participants with Cesarean delivery (CD)	5 minutes
Primary	Deep venous thrombosis	diagnosed by imaging tools such as venous Doppler ultrasound of the lower limbs	5 minutes
Primary	Pulmonary embolism	diagnosed by imaging tools such as angio-CT scan of the thorax.	5 minutes
Primary	Pregnancy loss at less than 24 weeks' gestation		5 minutes
Primary	Intrauterine Fetal Demise (IUFD)	Pregnancy loss at 24 weeks or more, or the delivery of a neonate weighing more than 500 g	5 minutes
Primary	Maternal death	Maternal death	5 minutes
Primary	Low birth weight	birth weight at less than 2500g	5 minutes
Primary	Number of participants with Neonatal intensive care unit (NICU) admission	Number of participants with Neonatal intensive care unit (NICU) admission	5 minutes
Primary	Percentage of participants with Neonatal intensive care unit (NICU) admission	Percentage of participants with Neonatal intensive care unit (NICU) admission	5 minutes
Primary	Number of participants with APGAR score (Activity, Pulse, Grimace, Appearance, Respiration score) at 5 minutes < 7:	The score minimum is 0 and maximum is 10. Higher score means better outcome.	5 minutes
Primary	Percentage of participants with APGAR score (Activity, Pulse, Grimace, Appearance, Respiration score) at 5 minutes < 7:	The score minimum is 0 and maximum is 10. Higher score means better outcome.	5 minutes
Primary	Number of participants with Respiratory distress at birth	Number of participants with Respiratory distress at birth	5 minutes
Primary	Percentage of participants with Respiratory distress at birth	Percentage of participants with Respiratory distress at birth	5 minutes
Primary	Neonatal death		5 minutes
Secondary	Number of participants with Delivery < 32 weeks		5 minutes
Secondary	Percentage of participants with Delivery < 32 weeks		5 minutes
Secondary	Number of participants with Spontaneous delivery < 37 weeks		5 minutes
Secondary	Percentage of participants with Spontaneous delivery < 37 weeks		5 minutes
Secondary	Number of participants with Fetal distress	referred to bradycardia, recurrent late or variable deceleration on antepartum or intrapartum cardiotocogram.	5 minutes
Secondary	Percentage of participants with Fetal distress	referred to bradycardia, recurrent late or variable deceleration on antepartum or intrapartum cardiotocogram.	5 minutes
Secondary	Number of participants with Unscheduled cesarean delivery		5 minutes
Secondary	Percentage of participants with Unscheduled cesarean delivery		5 minutes
Secondary	Postpartum hemorrhage	defined as the estimated blood loss of > 500 mL	5 minutes
Secondary	Number of participants with Intraventricular hemorrhage		5 minutes
Secondary	Percentage of participants with Intraventricular hemorrhage		5 minutes
Secondary	Umbilical cord pH		5 minutes
Secondary	Small for gestational age (SGA)	it refers to an estimated fetal weight of less than the 10th percentile	5 minutes
Secondary	Large for gestational age (LGA)	it refers to an estimated fetal weight of more than the 95th percentile	5 minutes