Prospective non-interventional registry study entitled:Peripartum outcome in vaginally targeted final pelvic births and influencing factors

Recruiting

• Conditions: O32.1; Maternal care for breech presentation

• Registration Number: DRKS00025030
• Lead Sponsor: Zentrum für Frauenheilkunde und Geburtshilfe Universitätsklinikum Frankfurt am Main

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

PATIENT REGISTRATION:
- Mother's date of birth (month/year): (mm/yyyy)
- Date of delivery (month/year): (mm/yyyy)
- Birth book number
BASIC DATA:
- Gravidity (number) / parity (number) / abortion/interruption (number) / EUG (extrauterine pregnancy) (Z
- Height (in cm): (number without decimal place)
- Weight before SS (in kg): (number without decimal place)
- BMI (before SS)
-
PREGNANCY:
- Pelvic diagnosis
? CVO (in cm)
- Condition after uterine surgery/sectio? (yes/no)
- Diseases/complications during pregnancy? (Yes/no) Case yes: type of
Disease/complication?
? Preeclampsia (yes/no)
? Gestational diabetes (yes/no).
- GDM, insulin dependent (yes/no)
- GDM, diet-controlled (yes/no)
? Preterm labor/cervical insufficiency (yes/no)
? Cervical insufficiency (cerclage, pressor insertion) (yes/no)
? Preterm labor indicators (rupture, prolapse, hemorrhage, opening of uterine orifice,
Contractions) (yes/no)
? abnormal condition of uterus and female genital tract (U.bicornis,
U.subseptus, fibroids, U.myomatosus, vagina subsepta, scars) (yes/no).
? Placental disorders(yes/no) If yes: what type of placental disorders?
- Placenta praevia (yes/no).
- Placental insufficiency, abruption,hemorrhage (yes/no).
? PPROM (premature rupture of membranes < SSW 37+0) (yes/no).
? SGA/IUGR (yes/no).
? Physical limitation (malformations, orthopedic problems, short stature,
Heart defect)
? Blood coagulation (factor disorders, thrombosis, embolism, thrombocytopenia)
? (Systemic) pre-existing conditions (e.g., hyper-/hypotension, hyper-/hypothyroidism,
Diabetes, anemia, obesity, neurodermatitis) (yes/no).
? chronic infections (hepatitis,HIV) (yes/no)
? Alcohol/drug abuse, methadone substitution
? Other diseases/complications (free field) (yes/no)
? If no: above fields visible but not editable.

BIRTH:
- Time of delivery: SSW [number+number] - e.g., 37+6
- TYPE of Breech
? complete breech = both legs bent upwards (yes/no)
? incomplete rear- foot- breech = one foot up, one foot down(yes/no)
? complete rear- foot- breech= both feet down (yes/no)
? baby standing in the uterus (yes/no)
? legs and head to the right/ left, belly or back down (yes/no)
- Mode of delivery:
? Vaginal spontaneous delivery (yes/no)
? Primary sectio(yes/no)
? Secondary sectio (yes/no)
? Emergency sectio (yes/no)
? Sectio on request (yes/no)
- Indicators for sectio
? disproportion, CVO <12cm, macrosomia (yes/no).
? maternal indication (pre-eclampsia, HELLP- syndrome, infection, hepatitis/ HIV,
Thrombosis, severe other (syst.) disease) (yes/no).
? AIS, v.a. AIS, infection (yes/no).
? other fetal indications (yes/no).
- Birth position
? Supine position (yes/no)
? quadrupedal position (yes/no)
Standing (yes/no)
- Head release maneuver (yes/no) If yes, what type of head release?
? Bracht handle (yes/no)
? Veit-Smellie hand grip (yes/no)
? Frank nudge (yes/no)
- Arm release maneuver (yes/no) If yes, what type of head release?
? Bickenbach (yes/no)
? Classic arm release (yes/no)
? Lövset (yes/no)
? Müller (yes/no)
? Louwen maneuver (yes/no)
- Path CTG (yes/no)
- Birth duration (in minutes)
? Total duration of birth
? Duration of opening period (in minutes)
Duration of expulsion period (in minutes)
- Birth arrest (yes/no) If yes, what time of birth period?
? Opening period (yes/no)
? Expulsion period (yes/no)
- Signs of infection during labor (fever, CRP, ß-hemolytic streptococci, varicella) (yes/no)
- PDA (yes/no)
- Premature rupture of membranes (yes/no)
- Prolapse of body pa

Exclusion Criteria

missing patient's consent
pathology in pregnancy
gestational diabetes
Uterine malformations
Uterine surgery with caval opening
Placental abnormalities
Pelvic abnormalities
Fetal growth retardation
Transverse position
Fetal malformations

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main objective is to increase knowledge in the field of diagnostic or <br>therapeutic pathways in women with a fetus in BEL.<br><br>Evaluation criteria, expected effects, influencing factors and their statistical evaluation<br>will be defined in the context of the hypotheses to be generated for future research projects. <br>which will be answered on the basis of the data of this registry.

Secondary Outcome Measures

Name	Time	Method
fetale Outcome