## Protocol Section
### Identification Module
**NCT ID:** NCT06426732

**Brief Title:** The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females

**Official Title:** The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females

#### Organization Study ID Info
**ID:** 2022-919
#### Organization
**Class:** OTHER
**Full Name:** The Second Hospital of Shandong University
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-18

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The Second Hospital of Shandong University

#### Responsible Party

**Investigator Affiliation:** The Second Hospital of Shandong University

**Investigator Full Name:** Linlin Cui

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The incidence of gestational hypertension and preeclampsia in the assisted reproductive technology population during pregnancy was significantly higher than that in the general normal pregnancy population. The use of assisted reproductive technology in this population due to infertility is often accompanied by many hypertension-related factors. We established a prospective cohort study based on assisted reproductive technology pregnancy population and natural pregnancy population. Through continuous monitoring of blood pressure changes and other risk factors during pregnancy in the two groups, we explored the trajectory trend and inflection point of assisted reproductive technology pregnancy population blood pressure during pregnancy. Through factor analysis, the risk factors of elevated blood pressure during pregnancy can be clearly identified, so as to carry out early intervention and strengthen the control of risk factors of elevated blood pressure in assisted reproductive technology population, in order to expect benign maternal and infant outcomes.

### Conditions Module

**Conditions:**

- Blood Pressure

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** Natural pregnancy group

#### Arm Group 2

**Label:** Assisted Reproductive Technology Group

### Outcomes Module

#### Primary Outcomes

**Description:** The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females

**Measure:** The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females

**Time Frame:** from pregnancy to delivery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

-Exposure group:

Mother: Seen in the obstetrics department of our hospital and meet the following conditions at the same time:

1. Complete at least one cycle of IVF or ICSI, PGD or IVM treatment (including natural cycles);
2. Clinical pregnancy was obtained after treatment. Offspring: Offspring born after in vitro fertilization-embryo transfer technique.

   * Non-exposed group:

Mother: A mother who conceived naturally. Offspring: 1) Offspring born by natural pregnancy. 2) Offspring born from natural pregnancy of exposed mothers.

Exclusion Criteria:

* Unwilling to participate in this research;
* Unable to participate in this study due to special reasons, such as death, immigration, loss to follow-up;
* Hereditary diseases, mental diseases, malignant tumors, pre-pregnancy hypertension, uterine malformations and other reproductive organ malformations;
* Pregnant women who voluntarily terminate pregnancy due to non-preeclampsia factors;

**Maximum Age:** 45 Years

**Minimum Age:** 20 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** collect sixty patients in each group

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 13188936075@163.com

**Name:** Wenting Wang, M.D. Ph.D.

**Phone:** +86 17660082326

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Jinan

**Contacts:**

***Contact 1:***

- **Email:** 13188936075@163.com

- **Name:** cui lin lin, doctor

- **Phone:** 17660082326

- **Role:** CONTACT

***Contact 2:***

- **Name:** wang wen ting, doctor

- **Phone:** 13188936075

- **Role:** CONTACT

**Country:** China

**Facility:** Cui linlin

**Status:** RECRUITING

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
