## Protocol Section
### Identification Module
**NCT ID:** NCT03479879

**Brief Title:** Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

**Official Title:** Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage: A Prospective, Double-blind, Randomized Clinical Trial

#### Organization Study ID Info
**ID:** AS1731
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2018-12-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-01-29

**Type:** ACTUAL

**Last Update Submit Date:** 2019-01-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-12-20

**Type:** ACTUAL

#### Start Date
**Date:** 2018-03-21

**Type:** ACTUAL

**Status Verified Date:** 2019-01

#### Study First Post Date
**Date:** 2018-03-27
**Type:** ACTUAL
**Study First Submit Date:** 2018-03-21
**Study First Submit QC Date:** 2018-03-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ain Shams University

#### Responsible Party

**Investigator Affiliation:** Ain Shams University

**Investigator Full Name:** Mohamed S Sweed, MD

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal misoprostol alone in induction of second trimestr miscarriage.

### Conditions Module

**Conditions:**

- Miscarriage

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ACTUAL

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Estradiol

- Drug: Misoprostol

**Label:** Estradiol + Misoprostol

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Placebo Oral Tablet

- Drug: Misoprostol

**Label:** Placebo + Misoprostol

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Estradiol + Misoprostol

**Description:** Estradiol

**Name:** Estradiol

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo + Misoprostol

**Description:** Placebo

**Name:** Placebo Oral Tablet

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Estradiol + Misoprostol

- Placebo + Misoprostol

**Description:** Misoprostol

**Name:** Misoprostol

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Duration of induction of abortion

**Time Frame:** 24 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Maternal age more than 18 years old (age of legal consent).
* Gestational age between 12-26 weeks.
* Hb level \> 10 g/dL.
* BMI between 25 kg/m2 and 35 kg/m2.
* Missed abortion.
* Living fetus with multiple congenital malformations incompatible with life.
* PPROMS with drained liquor and parents are consenting for termination of pregnancy.

Exclusion Criteria:

* Maternal age less than 18 years old.
* Gestational age less than 12 weeks or more than 26 weeks.
* Hb level \< 10 g/dL.
* Scared uterus (previous myomectomy - cesarean section - hysterectomy and ruptured uterus).
* Polyhydramnios.
* Anencephaly.
* Fibroid uterus.
* BMI less than 25 kg/m2 and more than 35 kg/m2.
* Coagulopathy.
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or estradiol.
* Placenta previa.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Ain Shams University Maternity Hospital

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M21

- Name: Abortion, Spontaneous

- Relevance: HIGH

- As Found: Miscarriage

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000022

- Term: Abortion, Spontaneous

### Intervention Browse Module - Ancestors

- ID: D000004967

- Term: Estrogens

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000000020

- Term: Abortifacient Agents, Nonsteroidal

- ID: D000000019

- Term: Abortifacient Agents

- ID: D000000897

- Term: Anti-Ulcer Agents

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000010120

- Term: Oxytocics

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M266279

- Name: Estradiol 17 beta-cypionate

- Relevance: LOW

- As Found: Unknown

- ID: M266280

- Name: Estradiol 3-benzoate

- Relevance: LOW

- As Found: Unknown

- ID: M8108

- Name: Estradiol

- Relevance: HIGH

- As Found: Cell lymphoma

- ID: M234941

- Name: Polyestradiol phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M18979

- Name: Misoprostol

- Relevance: HIGH

- As Found: Liquid

- ID: M8116

- Name: Estrogens

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M4188

- Name: Antacids

- Relevance: LOW

- As Found: Unknown

- ID: M4219

- Name: Anti-Ulcer Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016595

- Term: Misoprostol

- ID: D000004958

- Term: Estradiol

### Misc Info Module

- Version Holder: 2024-05-24
